Overall, pain at rest and during movement was slightly lower after the intervention. Significant changes were observed after thoracic surgery, small joint surgery and other minor surgical procedures. The rather moderate decrease in pain likely relates to a reasonable pre-existing pain management and to detached improvements in certain patient subgroups. Interestingly, specific analyses revealed significantly lower post-test pain as compared to pre-test pain only in patients without pre-existing chronic pain. Side effects related to pain medication were significantly lower after intervention. Our data show, for the first time, benefits of a perioperative teaching programme in a multicentre approach. Pain ratings improved mainly in specific subgroups of patients, e.g., small surgical procedures and patients without preoperative pain. Thus, general improvement is possible but special attention should be paid to the group of patients with preoperative pain.Many studies still indicate insufficient pain management after surgery, e.g., in patients after small- or medium-size operations. Yet it is still uncertain if postoperative pain based on patient-related outcomes can be improved by implementing guideline-related programmes in a multicentre approach. Adult patients in six hospitals in one German city were included in this prospective study. Data collection took place twice in each hospital, once before and once after implementation of concepts and in-house training. Pain and pain-related aspects were assessed one day after surgery and compared between the pre- and post-test group including subgroup analysis of certain surgical procedures by using Student’s t-tests, Mann-Whitney U tests and chi-square tests (alpha Although established guidelines , 2 and eOne of the factors moderating postoperative pain intensity is the extent of the surgical procedure itself. As indicated recently , pain inThere are ongoing efforts to improve postoperative pain under “real-life” conditions. Besides humanitarian reasons, it is well established that severe postoperative pain is associated with physical problems like pulmonary or cardiac complications, longer hospital stays and higher mortality. In turn, optimal pain management with, for instance, epidural analgesia is able to significantly reduce mortality . PatientOnly very few studies address possibilities to improve postoperative pain under real-life conditions. Among those available are either single centre studies , studiesThis prospective study is part of the health care services project ‘Action Alliance Pain-Free City Muenster’, which was conducted from January 2010 to December 2013 with a pre-post-test design. Details of the entire project have been published elsewhere . PostopeEthical clearance was given by the ethics committee of the Institutional Review Board of the University of Muenster (Ref. 2010-010-f-S). All participants were informed about voluntary participation and the guaranteed right to withdraw from the study at any time without repercussions. Respondents gave written consent and were fully informed about their rights to privacy. Data of participants were stored electronically and pseudonymised with randomly generated codes.In each hospital, all patients on the first day after an elective surgery were included consecutively within a predefined time of four weeks (convenience sample), provided that they matched the inclusion criteria. The surveys took place from Tuesday to Saturday as elective surgeries are realised on weekdays only. Exclusion criteria were refusal to participate, no written consent, age younger than 18 years, cognitive impairment, psychiatric disorders, fragile general state of health (based on diagnoses from ward physician), insufficient German language capabilities or staying in the intensive or intermediate care unit.Data collection for the pre-test phase was carried out by trained study assistants over a period of 4 to 6 weeks in each hospital (May to August 2010). After a six-month intervention phase, the post-test phase took place from September 2011 to February 2012, again over a period of 4 to 6 weeks in each hospital.First, the status-quo of standard regulations for pain management of each hospital was analysed by the research team. These written policies and regulations combined with the pre-test survey results were used to identify recommendations and intervention packages for each hospital.Patients were examined with netbook-based standardised questionnaires by self-interview or interviewed by specially trained research assistants. The 38-item questionnaire was adapted from a prior study [Biometrical  and medical , code of disease (ICD), documented disease, scheduled analgesics & analgesics on demand (PRN), presence of malignant tumour) data were collected directly from the patients’ medical records and clinical data sheets.The outcome variables “pain intensity” and “severity of side effects” were treated as ordinal scale measures. For the rated pain intensity on the 11-point NRS, cutoff values , 8 were min = 14) were built to test differences in pain outcome variables. These surgical subgroups were classified on the basis of the documented surgical procedures and categorized by their location and extent of the surgery . Pre-post-comparisons were carried out for selected single surgical procedures based on the OPS-codes. Similar pain-associated procedures were assigned to one surgical group resulting in four procedures .Because the total sample showed heterogeneity relevant to the outcome on postoperative pain, we performed analyses of primary and secondary outcome variables between the pre- versus post-intervention group in pre-defined procedure surgical subgroups. Twelve comparable subgroups with sufficient sample sizes . The goal was to reach a high and comparable standard of pain assessment, medical documentation and treatment on every surgical ward in all hospitals. These implementations were supported by internal trainings in the hospitals as well as by the research group.All statistical analyses were conducted using SPSS 21.0. Sample characteristics were primarily analysed applying descriptive statistics. Pre-post-comparisons for normally distributed variables were executed using Student’s t-test for independent samples. Differences in ordinal or non-normal distributions were statistically tested using Mann-Whitney-U-Test. In case of dichotomous variables, Pearson chi-square analyses and Cramer’s V (V) were exerted. In general, type one error was set to alpha = 0.05 and two tailed p-values were used to assess statistical significance.In the pre-intervention period, a total of 1,486 patients from 6 hospitals were screened for participation. As a result of excluding, declined participation and data cleansing , data frPain at rest was significantly higher in the pre-intervention phase (n = 706) compared to the post-intervention phase  . Pain duIn general, unrelated to the pre- or post- intervention group, median pain ratings at rest were 2 or lower and pain ratings during movement were 4 or lower after almost every surgical procedure . The mosComparison between pre- and post-intervention groups revealed similar or lower median pain ratings and less patients with pain ratings above cutoff in the post-intervention group compared to the pre-intervention group regardless of the type of surgery . SignifiBecause reliable pre-post-comparisons are best in groups of patients with exactly the same surgical procedure, we further analysed and compared pre-post-data from single surgical procedures based on the OPS-Codes . As descrest>3 or NRSmovement>5 (“patients with significant preoperative pain”) and for patients with pain below cutoff  before surgery for the total sample and for selected surgical groups  of patients in the pre-intervention group reported significant preoperative pain at rest before surgery whereas 44.3% (n = 205/463) of patients in the post-intervention group reported significant preoperative pain. Preoperative pain during movement above cutoff was reported by 46.6% (n = 185/397) in the pre-intervention and 52.8% (n = 243/460) in the post-intervention group. Patients without significant preoperative pain experienced significantly lower postoperative pain at rest as well as during movement in the post-intervention versus the pre-intervention group. In contrast, there was no difference in postoperative pain at rest and during movement in patients with significant preoperative pain in the pre- versus the post-intervention group .In patients with major joint surgery , postopeAfter visceral surgeries, no significant differences in pain intensity—neither for postoperative pain at rest, nor for pain during movement—were observed regardless if patients had preoperative pain above cutoff, or not.Patients after thoracic procedures reported less severe nausea, vomiting and fatigue by trend (p<0.10) . In patiThis is the first multicentre study prospectively investigating the effect of a perioperative pain improvement approach in a pre-post design based on patient-related outcome. Our data show an improvement of pain ratings after the intervention in the total sample and in select subgroups of patients after certain surgical procedures, e.g. small surgical procedures. In addition we found a consistent improvement of pain ratings in patients without pre-existing chronic pain before surgery but not in patients with pre-existing chronic pain. Finally, potential side effects of analgesics were reduced in the post-test sample indicating that improvement in pain management might not be associated with more side effects.Our study was successful in improving acute pain after surgery in patients from six hospitals with a wide and typical spectrum of different surgical procedures in a medium size city  in Germany. We included patients regardless of the type or size of the surgical procedure. However, to acknowledge a possible imbalance of procedures, we performed subgroup analyses with regard to the type of the surgical procedure. Median pain scores were significantly lower in the post-test group compared to the pre-test group in patients after small joint surgery, thoracic surgery and skin tumour excision. Thus, direct comparison between groups of patients with comparable surgical procedures further indicates an improvement due to the intervention and supports the effect of the intervention. The improvements are of clinical relevance, for instance if the numbers of patients with pain ratings above cutoff values are compared .Breaking it down to single OPS-defined surgical procedures, we were able to compare some different surgical subgroups with sufficient numbers of patients. Again, pre-post comparison of single procedures showed a meaningful decrease in pain ratings in the post-intervention skin cancer subgroup, a small but insignificant decrease in the thyroidectomy. Whereas the first two examples indicate success of the intervention, the latter shows difficulties in improvement in certain surgical subgroups . HoweveAlthough significant, the reduction in pain ratings was in some surgical groups rather small. One plausible explanation are the low median pain scores before intervention in our pre-test sample (NRS = 2 at rest and NRS = 4 during movement) indicating an already successful pain management for these procedures before intervention. In fact, these pain scores are comparable to those in single centre studies after an intervention (mean of 1.6 at rest and 3.6 during movement)  and muchAs indicated in a recent large data analysis, preoperative pain is one major risk factor for high pain scores after surgery irrespective of the type of the procedure . TherefoA successful pain improvement project should imply that side effects are not increased. Reducing pain scores may increase symptoms which are most likely related to analgesics’ side effects because more drugs are being applied. Although we were able to improve pain scores, typical side effects of analgesia were either lower or statistically indifferent in the post-intervention group. Interestingly, in patients after thoracic procedures (where pain ratings were reduced in the post-intervention group) nausea, vomiting and fatigue were lower in the post-intervention group indicating that pain reduction was not accompanied by more side effects. The most likely explanation is that strong opioids were administered related to the patients’ individual need after intervention. Furthermore, oral opioids were administered more often and intravenous opioids were administered less frequently after intervention. Thus, higher opioid doses inducing side effects were avoided explaining reduced incidence and severity of side effects. Pain management which is basically adapted to the patients’ needs is not and should not be automatically associated with an increase in side effects.The strength of our study is the pre-post-design under real-life conditions rarely applied to examine in a multicentre approach an improvement in pain management after surgery. However, one limitation of this design is that we evaluated a non-random sample to channel a representative real-life sample of patients. The non-random sampling caused heterogeneity of procedures limiting comparison of the total group of patients. However, we tried to overcome this limitation by comparing results from certain types of procedures. Furthermore, it was only possible to analyse some specified sub-groups of patients after certain surgical procedures due to small sample sizes.Nonetheless, due to the non-random selection procedure we cannot rule out the possibility of certain confounders. Because sample characteristics differed significantly between pre- and post-test, we’ve applied further multivariate statistics to address this issue. Only the significant reductions of pain intensity in patients with skin tumour surgical procedures seem to be confounded by sample characteristics—fractional by age and sex, but especially by the differing prescription of PRN analgesics before and after intervention. In fact, we interpret this as a positive effect with regards to content: We have reason to believe that this is to a significant part because of our introduced intervention and training programme, whereas the necessity of a target-oriented PRN usage against the background of the individuals’ pain situation was specifically highlighted. However, further potential confounders  were neither controlled nor assessed and should be controlled in future studies.Similar to most other studies, we examined postoperative pain only on the first day after surgery and only in hospitalised patients. These aspects should be focused on in the future. The described intervention was adapted to the results and circumstances in the individual hospital. In fact, after analysing the pre-test results and protocols, we had to deal with different problems in pain management in each particular hospital. Regional analgesia techniques were included in all hospitals from the beginning, e.g. for major orthopaedic and visceral procedures. However, aspects related to the management of pain after more minor or medium size procedures differed significantly. Therefore, aspects related to optimal measures of pain, cutoff points for intervention and an algorithm for treating pain after surgical procedures without regional analgesia techniques was main part of the intervention and trained individually. Inasmuch, the intervention was not explicitly standardised but very specific to the individual situation at hand in each hospital. Further studies are now needed to properly characterise important aspects relevant to a successful intervention programme.S1 File(SAV)Click here for additional data file.S1 Table(DOCX)Click here for additional data file.S2 Table(DOCX)Click here for additional data file.S3 Table(DOCX)Click here for additional data file.


The effectiveness and safety of switch from oral oxycodone to fentanyl patch is little known. Here, we investigated if early phase opioid switch from low dose of oral oxycodone to transdermal fentanyl matrix patch provided any benefits for patients with thoracic malignancy and stable cancer-related pain.This open-label two-centered prospective study enrolled patients with thoracic malignancy suffering persistent malignancy-related pain with numeric rating scale of pain intensity ≤ 3 which had been controlled by oral oxycodone ≤ 20 mg/day. Eligible patients switched from oral oxycodone to 12.5 μg/h of transdermal fentanyl matrix patch. The dose was allowed to be titrated upwards every 3 day by 25-50%, except for the first increase from 12.5 μg/hr to 25 μg/hr,until achieving adequate pain control. The data on patients’ global assessment scores measured on a five-step scale, an 11-point numeric rating scale of pain intensity, the severity of adverse effects using a four-point categorical rating scale, and the Epworth sleepiness scale questionnaire were collected for 15 days.p < 0.05), and 90% and 78% of patients remained to receive the minimum dose of fentanyl patch on day 8 and 15 from the opioid switch. There was a significant difference in sleepiness throughout the study period, though no difference was detected in pain intensity and other adverse effects.Forty-nine eligible patients were analyzed. Overall patients’ satisfaction score significantly improved from day 1 (2.7 ± 0.9) to day 15 (2.3 ± 0.9) (Transdermal fentanyl matrix patch is an alternative analgesic option for a stable cancer pain in patients with thoracic malignancies. Cancer-related pain is the most important concern in patients suffering cancer. More than 80% of patients with advanced disease experience cancer-related pain caused largely by direct tumor invasion . Cancer-Opioids are the mainstay of analgesic therapy for moderate to severe cancer-related pain, according to the current guidelines ,3. Oxyco®Patch . In 2008, a transdermal fentanyl matrix patch , a new TTS that contains fentanyl dissolved in the adhesion layer, has become available in Japan. The smallest size of the matrix patch, with fentanyl release rates of 12.5 μg/h, makes it possible to switch from lower dose of other opioid and then gradually titrate to the effectual dose [On the other hand, the high lipid solubility and low molecular weight of fentanyl is suitable for transdermal administration. In 2002, a transdermal therapeutic system (TTS) for fentanyl incorporating a gel reservoir technology was first marketed as the Durotepual dose . Fentanyual dose . In anotual dose ,14 and aual dose  also indual dose . Howeverual dose .Opioid switch is a therapeutic maneuver aiming at improvement of analgesic response and reduction of adverse effects . The manIn this study, we investigated if early phase opioid switch from low dose of oral oxycodone to transdermal fentanyl matrix patch provided any benefits for patients with stable cancer-related pain.®, Shionogi-Pharma, Japan). Exclusion criteria were as follows; 1) prior history of allergy or hypersensitivity to opioids, 2) prior history of opioid abuse, 3) clinically significant cardiac, renal or hepatic insufficiency, 4) increased intracranial pressure or impaired cognitive function, 5) active and extensive skin disease precluding application of the transdermal delivery system, 6) persistent fever of 40 degrees Celsius or over, 7) pregnancy, lactation and suspicion of being pregnant, 8) prior use of any opioid-antagonists within 2 days before switching to fentanyl patch. Concomitant treatments such as chemotherapy and radiotherapy at the enrollment were accruable.Patients with thoracic malignancy-related pain were recruited in Osaka Police Hospital and Osaka University Hospital. The patients who met all the following criteria were eligible; 1) confirmed diagnosis of thoracic malignancy, 2) age ≥ 20 years, 3) persistent malignancy-related pain refractory to non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen, 4) numeric rating scale (NRS) for pain ≤ 3 for at least two consecutive days by low dose (20 mg/day or less) of oral oxycodone  medications per day. Time of recording diary was arbitrary. The diaries were collected after 15 days of fentanyl patch treatment. The patients' global assessment scores were also rated using a five-step scale  [All patients recorded the following data daily for 15 days of fentanyl patch treatment; 1) pain intensity using an 11-point NRS , 2) the severity of adverse effects  using a four-point categorical rating scale , 3) the number of defecation per day, 4) the Epworth sleepiness scale (ESS) questionnaire except for the question on sleepiness during driving a car because strong opioids are not permitted for drivers in Japan, 5) the frequencies of immediate-release oxycodone (Oxinormied = 5)  on days The primary endpoint in this study was patients' global assessment scores. Secondary endpoints were pain intensity, adverse effects and use of rescue oxycodone.The study protocol was approved by the Institutional Review Board of Osaka University Hospital and the Osaka Police Hospital ethics committee, adhered to the principles outlined in the Guideline for Good Clinical Practice (January 1997) and Declaration of Helsinki (1996), and registered as UMIN000011067. Written informed consent was obtained from all patients before commencement of the study.®MT patch reporting that the patients’ satisfaction was 89.4% [We expected that 85% of patients would give the global assessment scores 1 to 3, on the basis of the data from a previous Japanese clinical trial of Durotepas 89.4% . The estListwise deletion was adopted in cases in which we missed data at opioid switch (day 1). Patients who dropped out without completion of 15-day patch treatment were also deleted from analysis. Missing data at days 8 and 15 from opioid switch were handled using last observation carried forward (LOCF) imputation technique.p < 0.05. All statistical analyses were performed using Statcel statistical package .The data for normally distributed continuous variables, discrete variables, and categorical variables are expressed as the mean ± standard deviation (SD), median with range, and frequency. Friedman test, with a post-hoc Steel test, was used to compare longitudinal changes in numeric and categorical rating scales and ESS questionnaire scores. Significance was set at Although enrollment to this study was planned to complete within 2 years, only 50 patients were accrued for 4 years, despite of 2-year extension of the study period. Therefore, this study was terminated in December 2012 because of delayed accrual. The final accrual did not reach 60 patients, the preplanned sample size.From February 2009 to December 2012, a total of 50 eligible patients switched opioids. Almost all patients completed 15 days of fentanyl matrix patch treatment except one patient who suddenly died of cancer progression on the 13rd day from opioid switch. During the study period, 51% and 24% of patients concomitantly received chemotherapy and radiotherapy, respectively. The baseline characteristics are shown in Table p < 0.01). The proportion of patients in category 1 or 2 (‘very satisfied’ or ‘satisfied’) for the patient's global assessment score increased from 43% on day 1 to 63% on day 8 and 61% on day 15, while the proportion of patients in category 1–3  hardly changed from 87% on day 1 to 91% on day 15  (Tables Oxycodone doses on day 1 differed from 10 to 20 mg/day. Fentanyl matrix patch dose remained 12.5 μg/h in 44 patients (90%) on day 8 and 38 patients (78%) on day 15, and increased up to more than 25 μg/h in 10 patients (20%) during the study period  including various kinds of prior opioid; oral oxycodone < 30 mg/day (69.4%), intravenous fentanyl injection < 0.3 mg/day (1.2%) and oral, transanal or intravenous morphine (29.4%), 2) recruiting patients with various types of primary cancers, including 34% of respiratory cancer, 3) assessing patients’ global pain assessment only at day 10, during third patch application, or the day of protocol withdrawal . We focuet al., in which the rate of ‘very satisfied’ and ‘satisfied’ increased over time after opioid switch to fentanyl patch [The most important finding of our study was that patients’ satisfaction was improved by opioid switch from oral oxycodone to fentanyl patch. More than 80% of patients did not feel dissatisfied in the patients' global assessment scores, which met the primary endpoint. Contrast to no difference in ESS score, sleepiness was significantly improved by opioid switch. Moreover, favorable changes were conceivably noted in constipation, though the improvement in constipation did not reach statistical significance. In the four-point categorical rating scale of sleepiness , the number of patients with scale 0 increased from 6 on day 1 up to 19 on day 15, while that with scale 1 decreased from 29 down to 20. In the assessment of constipation, all 5 patients with scale 2 or 3 on day 1 improved to scale 0 or 1 on day 15, while one patient with scale 0 on day 1 deteriorated into scale 2 on day 15 . Five of these 6 patients converted opioids on day1 in our hospitals, and recorded their diaries on day 1 before or at the same time as the first application of fentanyl patch. Because we did not know when the remaining one outpatient had written diaries on day 1 at home, this patient might have severer pain than usual by the confusion from oral oxycodone to fentanyl patch. Fifth, we did not grasp the precise number of ineligible patients who dropped out during oxycodone treatment due to uncontrollable pain by 20 mg/day of oral oxycodone. Thus, we failed to clarify the proportion of eligible patients for this opioid switch maneuver in all patients with thoracic malignancy-related pain requiring strong opioid. Based on the study limitations described above, we are considering a cross-over trial comparing in pain control and adverse severity between fentanyl patch and oral opioid for cancer-related pain, instead of a randomized blinded controlled trial. Our study group is still too small to conduct such a high level of trial.Transdermal fentanyl matrix patch is an alternative analgesic option for a stable cancer pain in patients with thoracic malignancies.The authors declare that they have no competing interests.TK designed the study. SM and TK analyzed the data and wrote the manuscript. All authors accrued and managed patients, collected data, read and approve this manuscript, and agree to its submission.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-684X/13/46/prepubThe patients’ distribution of adverse events.Click here for file


Background. Renal colic is a medical emergency due to the rapid onset and devastating nature of its pain. Opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are both used as first-line choices in its management. Aim. This study aimed to compare the efficacy and safety of opioids and NSAIDs in the management of acute renal colic. Methods. One hundred and fifty-eight patients were divided into two groups (n = 79) and received either 10 mg morphine or 100 mg indomethacin suppositories. The severity of pain was measured using verbal numeric rating scale at baseline and 20, 40, 60, and 90 minutes after the administration of analgesics. Drug side effects as well as patients' vital signs were also recorded. Results. The mean decrease in the pain score during the first 20 minutes was significantly higher among those who received morphine suppository. However, no significant difference was observed between the two groups regarding the mean decrease in pain score during the first 40, 60, and 90 minutes after the admission. Prevalence of drug side effects or changes in the vital signs was not significantly different between the two groups. Conclusions. Morphine suppositories seem to be more efficient in achieving rapid pain relief comparing to indomethacin. Renal colic, as the most common presentation of ureteral calculi, is characterized by a sudden onset and severe sense of pain in the flanks which may radiate to the hypochondrium . This paThe current standard management of pain during acute renal colic episodes includes administration of opioids as well as nonsteroidal anti-inflammatory drugs (NSAIDs) both alone and in combination with each other. While opioids take advantages of being inexpensive, potent, and titratable, their usage is limited due to the fear of respiratory depression, drug dependency, and potential drug abuse by mimicking renal colic symptoms in order to receive opioids . MorphinCurrently, the choice between opioids and NSAIDs at the clinical setting is highly dependent on clinician's personal preference and experience as well as institutional protocols while there is limited data in order to compare the outcome of these drugs in the management of acute renal colic . Conside2014050514297N2) was performed between March 2011 and March 2013 in the emergency department of Imam Hospital and Shariati hospital, two tertiary care university affiliated teaching hospitals. The Institutional Review Board has reviewed and approved the process of this study.The current randomized double-blind clinical trial (IRCT registration ID: M) and standard deviations (SD) of 24.7 and 9.1 for indomethacin and 27.4 and 9.1 for morphine, using the following formula: n = 79). Based on the patients' clinical presentation, the diagnosis of renal colic was primarily made by triage nurse and was then confirmed by the emergency medicine resident and the attending physician. The process of the study was explained to all participants and they were asked to fill an informed consent before being entered into the study. Patients were ensured that their personal and clinical data would not be revealed under any circumstances and their names were replaced with codes before data entry to ensure data confidentiality. The exclusion criteria were as follows: unwillingness to participate in the study or to receive suppository analgesics, pregnancy, breastfeeding, a history of current or past drug abuse, analgesic intake during up to 4 hours prior to admission, long-term use of NSAIDs, a drug history of hypnotic drugs or phenothiazines, a history of drug hypersensitivity reaction due to morphine or NSAIDs, diarrhea, peritonitis, and a history of chronic diseases including liver disorders, renal disorders, respiratory problems, gastrointestinal problems, and endocrine disorders.Based on the previous studies, a minimum sample size of 79 for each group was desired . This waPatients either received 10 mg morphine suppository (group A) or 100 mg indomethacin suppository (group B) for the management of renal colic, respectively. In order to blind the observers as well as patients, morphine and indomethacin suppositories were placed into glass containers labeled as A and B and were administrated for patients by the resident of emergency medicine. Only pharmacy section manager of hospital was aware of the type of suppositories placed into A and B containers. The primary outcome of the study was change in the pain score. The secondary outcome of the study was the safety and tolerability of drugs as measured by hemodynamic changes and adverse effects. Assessment of pain was performed using 11-point numeric rating scale (from 0 for no pain to 10 for most severe pain possible) at the time of admission and 20, 40, 60, and 90 minutes later. Intravenous morphine with a dosage of 5 mg was suggested and administrated for each patient every 20 minutes if the pain remained the same or the patient reported only a minor pain relief. Drug adverse effects including nausea, vomiting, dizziness, and drowsiness as well as patients' vital signs were also assessed every 20 minutes. Demographic data including sex and age, pain score reported by patient at various points, the amount of analgesics needed for pain relief, and the duration of hospital stay was recorded for each patient.P values lower than 0.05 were considered as statistically significant.Data analysis was performed using SPSS software package for windows version 21 . Quantitative variables are expressed as mean ± standard deviation. Repeated measure analysis and chi-squared test were used in order to compare quantitative and qualitative variables between groups, respectively. Effect size (ES) was estimated with a 95% confidence interval (95% CI). P = 0.9, and ES = −0.01 [95% CI = −0.32 to 0.32]). The mean weight of the study population was 73.8 ± 10.4 kilograms which was not statistically different between groups A and B . Male to female ratio was also similar between groups A and B . A total number of 158 cases including 102 (64.6%) male and 56 (35.4%) female cases were enrolled in the current study . The meaP = 0.5, and ES = 0.1 [95% CI = −0.22 to 0.41]). The mean decrease in the pain score during the first 20 minutes after the admission was significantly higher among group A cases who received morphine suppository comparing to group B who received indomethacin suppository . However, no significant difference was observed between the two groups regarding the mean decrease in pain score during the first 40, 60, and 90 minutes after the admission . Vomiting was reported by 49% of patients in group A and by 51% of patients in group B which was also not significantly different . The prevalence of dizziness was 43.3% in group A and 56.7% in group B which was not significantly different . Dryness of the mouth was reported by 48% of patients in group A and by 52% of patients in group B which was also not significantly different . Allergic drug reactions were observed in 49.7% of patients in group A and in 50.3% of patients in group B which was also not significantly different . Nausea was reported by 52.7% of patients in group A and by 47.3% of patients in group B which was not significantly different (According to the results of the current study, the mean pain score was not significantly different between renal colic patients who received either morphine or indomethacin suppository. However, those who received morphine experienced a greater relief in pain during the first 20 minutes after the admission. No difference was observed between these two groups regarding the drug side effects including changes in the systolic and diastolic blood pressures.In one study, Cordell et al. investigated the differences regarding the efficacy in pain relief and probable side effects of intravenous morphine and indomethacin suppositories in patients with renal colic . Their fSince the analgesic effects of morphine and NSAIDs in renal colic are achieved via different pathways, one may conclude that the combination of these drugs would result in a better pain management or a decrease in the amount of needed morphine as a drug with a high potential for abuse. In a study by Engeler et al. two orally administrated NSAIDs, rofecoxib and diclofenac, were used in combination with morphine in the management of acute pain of renal colic . The meaSeveral studies have focused on finding an alternative analgesic for opioids in the management of acute pain of renal colic. Aside from NSAIDs, the efficacy and probable side effects of paracetamol have also been the subject of some investigations. In one study, Bektas et al. compared the intravenous administration of morphine and paracetamol among 146 renal colic patients who visited emergency department . Their fThe current study faces several limitations. First, some of the most serious side effects of analgesics used in this study could not be assessed due to the short period of follow-up. Drug abuse and dependence among those receiving opioids such as morphine and gastrointestinal bleeding among those receiving NSAIDs such as indomethacin are more likely to occur after patient's discharge from the emergency ward. However, it should be noted that the potential for abuse is particular for those who already have a history of drug abuse and should not be generalized to all patients after one admission. Second, it has been previously suggested that nausea and vomiting, which were expected side effects in this study, may affect patient's perception of pain by increasing the level of discomfort . FinallyIn conclusion, while the effect of analgesics on patients' vital signs and side effects of both morphine and indomethacin do not differ significantly, morphine suppositories seem to be more efficient in achieving rapid pain relief comparing to their indomethacin counterparts. Hence, morphine remains as a yet irreplaceable analgesic in the acute management of pain among renal colic patients.


Acute and severe pain is common in patients postoperatively and should be correctly managed. In the past years studies on preparing better postoperative pain control have resulted in development of postoperative pain management guidelines. Perhaps, one of the major improvements in managing postoperative pain is the development of the patient-controlled analgesia systems (PCA), especially through intra venous (IV), extradural and transdermal routes, which has resulted in marked improvements in acute postoperative pain management. Physicians administrate potent opioids for moderate to severe post-surgical pains. Morphine is the most commonly IV-PCA administrated analgesic. The fentanyl iontophoretic transdermal system (fentanyl ITS) is also another efficient option for pain management.The aim of this study was to compare the analgesic effects of these two routine postoperative pain control systems.We enrolled 281 patients  in this blind randomized controlled clinical trial, who had undergone an orthopedic surgery, with the mean age of 33.91 ± 14.45 years. Patients were randomly divided into two groups; in group A patients received IV-morphine PCA pump and in group B fentanyl transdermal patches were attached on patients’ arms. The severity of the pain was registered according to Visual Analogue Scale in specially designed forms by pain-trained nurses in two steps; first after the surgery and next before the beginning of analgesic effects. After 24 hours, the pain score was assessed again.No significant difference was observed in mean pain intensity score at the first patient assessment. Mean pain intensity scores were also similar in both groups at the last measured time point (P > 0.05). Differential pain intensity scores, showing the impacts of analgesic system on the pain experience of the patients was also similar between fentanyl patches (6.48 ± 2.20) and morphine PCIA (6.40 ± 1.80). (P > 0.05) Mean patient satisfactory score  was also similar in both groups (P > 0.05). The percentage of patients, whose differential pain intensity scores at 24 hours reached our pain management goal was similar between fentanyl and morphine groups (P > 0.05). The percentage of patients with at least one adverse event was significantly higher in fentanyl group (P < 0.05). The most frequent adverse events were nausea, vomiting and itching. In none of the groups, no patient experienced serious adverse events related to the studied medications.Although both pain killing therapeutic regimens are safe and effective for postoperative pain management, regarding the easy usage of the patches, lower risk of abuse and cost-effectiveness in the Iranian market, it is recommended for use in Iranian hospitals and trauma centers and in countries with similar socioeconomic situations. Pain is a mysterious sense in human beings and one of the commonest reasons for visiting a doctor . It coulMost of the analgesic regimens are intermittent, but pain is constant in post-surgical patients. Therefore it may lead to inadequate pain control , 11 or aThe fentanyl iontophoretic transdermal system (fentanyl ITS) is a self-programmed easy-applicable needle-free analgesic delivery way, designed for chronic and acute pain management, which could be helpful for postoperative adult patients. Although these patches provide the drug via the skin at a constant rate, the pharmacokinetic profile resembles IV fentanyl . TherefoThe aim of this study is to compare the analgesic effects of these two routine postoperative pain control systems.We enrolled 281 patients  in this blind randomized controlled clinical trial, with the mean age of 35.01 ± 14.49 years, after filling the inclusion criteria. They were fully informed and signed the ethical committee consent forms. Double blinding the study for the patients and all the staff involved was impossible, but our sampling, statistical analysis and medical history taking were performed by trained nurses who were completely blinded to therapeutic groups. All patients had undergone an orthopedic surgery in Shahid Kamyab Trauma Center and University Hospital, January 2011 to January 2012. Patients were randomly divided into two groups, for postoperative pain control.In group A patients received IV-morphine PCA pump. Each pump were filled by 20 mg morphine, diluted in 100 mL normal saline and set on 1 mg/h infusion rate. One bolus dose could be added by the patient if he/she felt undesirable pain. In group B fentanyl transdermal patches with total dose of 25 μg were used. Regarding the delayed action of the patches, they were attached upon the patients arm 18 h before the operation .The severity of the pain was registered, according to Visual Analogue Scale in especially designed forms, by pain-trained nurses in two steps; first after the surgery and then before the beginning of analgesic effects. No other analgesic drug was used during this time. Therefore, 24 hours after the surgery pain was assessed again. According to the surgery type, patients were enrolled in three categories: small surgeries on the fingers, and skin grafts were considered as the minor surgeries, moderate surgeries involved fractures of the forearm and foreleg and injury debridement and major surgeries involved pelvic surgeries , surgeries on femur, cervical and lumbar vertebrae, shoulder, amputations and prosthesis. The statistical analysis was done with SPSS software version 16.0, t-student and k-square test. Our profession staffs in vital statistics analysis were completely blinded to the therapeutic groups.A total of 281 patients were enrolled into the study . The mean age of the patients was 35.93 ± 15.73 years in fentanyl group and 34.13 ± 13.18 years in morphine PCIA patients (P = 0.296). No significant difference was observed between the two groups regarding patient characteristics . The disMean ± SD of patient satisfactory score , at the last assessment after the first 24 hours were similar in both groups  .The percentages of patients who reported satisfactory ratings of good or excellent, after the first 24 hours were 36.2% and 45.7%, respectively for the fentanyl ITS group vs. 42% and 42% for the morphine PCIA group. The difference was not significant (P = 0.746). There was no significant difference in mean pain intensity score, observed at the first patient assessment . Mean pain intensity scores were also similar in both groups at the last measured time point . Differential pain intensity scores which show the impact of analgesic system on the pain experience of the patients, was also similar between patients with fentanyl patches (6.48 ± 2.20) and morphine PCIA (6.40 ± 1.80) patients (P= 0.717).The percentage of patients whose differential pain intensity score reached our pain management goal, in 24 hours, was similar between fentanyl and morphine groups . The incidence of common adverse events was comparable between the two groups. The percentage of patients having at least one adverse event was significantly higher in fentanyl group . The most frequent adverse events were nausea and vomiting (0.152% of fentanyl ITS patients and 0.007% of morphine PCIA patients) and itching (0.028% of fentanyl ITS patients and 0.021% of morphine PCIA patients). No patient experienced serious adverse events (SAEs), related to the studied medications like ileus, somnolence, hernia or hypoventilation. Respiratory function was the primary safety measurement. No patient, neither in the fentanyl ITS group, nor in the morphine PCIA group experienced clinically relevant respiratory depression (bradypnea < 8 bpm and excessive sedation) .As judged by patient satisfactory scores, there was no statistically significant difference between two therapeutic regimens. The other efficacy variable, pain intensity score, confirmed the primary satisfactory data. In recent two decades, there have been many reports about safety and efficacy of PCA in post-surgery setting with potent opioids, especially with morphine or fentanyl -23.Our study supports the results of previous trials that demonstrated fentanyl ITS to be effective on postoperative pain , 24, 25,The inherent safety of PCIA is that the dosing frequency is controlled by the patient as needed for pain relief, reducing the possibility of overdose, as pain requirements are met. A meta-analysis of 15 randomized controlled studies showed that patients using PCA postoperatively, obtained significantly better pain relief than those using intramuscular analgesia, without increasing the adverse effects . This saOn the other hand, the most prevalent complications like itching, erythema, edema and discoloration, reported in literature about the fentanyl ITS group are related to the method of pain control . PanchalTo sum up, although both anti-pain therapeutic regimens are safe and effective for postoperative pain management, regarding the easy usage of the fentanyl patches, lower risk of abuse and cost-effectiveness in the Iranian market, its use is recommended in Iranian hospitals and trauma centers and countries with similar socioeconomic situations.


Despite the availability of effective medications and clinical guidelines for pain management, pain control is suboptimal in a sizeable proportion of patients with cancer pain. The National Comprehensive Cancer Network guidelines recommend a comprehensive and multimodal approach for management of cancer pain. We developed a mobile phone application, ePAL, based on clinical guidelines to empower patients for cancer pain management by prompting regular pain assessments and coaching for self-management.The objective of this study is to evaluate the effect of a multidimensional mobile phone-based pain management application, ePAL, on controlling cancer pain and improving quality of life in patients with cancer pain being treated at an academic palliative care clinic.The study will be implemented as a 2-arm randomized controlled trial with 110 adult patients with CP who own a mobile phone over a follow-up period of two months. Participants will be randomized to either the intervention group receiving ePAL and usual care or to a control group receiving only usual care. The brief pain inventory will be used to assess our primary outcome which is pain intensity. We will also evaluate the effect of the intervention on secondary outcomes which include the effect of the intervention on hospital utilization for pain crisis, quality of life, adherence to analgesic medications, barriers to pain control, anxiety and patient engagement. Instruments that will be used in evaluating secondary outcomes include the Brief Pain Inventory, Morisky Medication Adherence Scale, Barriers Questionnaire-II, Functional Assessment of Cancer Therapy–General, Edmonton Symptom Assessment System, Generalized Anxiety Disorder 7-item scale, and the Functional Assessment of Chronic Illness Therapy-Fatigue. The intention-to-treat approach will be used to evaluate outcomes. Our primary outcome, pain intensity, measured longitudinally over eight weeks, will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations.The study is still in progress. We hope to have results by the end of 2015.The multidimensional approach to pain management implemented on a mobile phone application could lead to significant improvements in patient outcomes.ClinicalTrials.gov NCT02069743; https://clinicaltrials.gov/ct2/show/NCT02069743 (Archived by WebCite at http://www.webcitation.org/6Qb65XGGA). In addition to the inherent pathophysiological effects associated with any cancer, pain is one of the most feared consequences of cancer ,2. CanceDespite the availability of guidelines from organizations such as the World Health Organization (WHO), at least 14% of patients with cancer pain have inadequate analgesia ,8. BarriCancer pain is multidimensional in nature and requires intensive self-management. It is important for affected patients to be coached, educated, and empowered to manage the pain they experience. Unfortunately, randomized clinical trials have been scarce on this subject . The staTraditionally, management modalities are administered during visits to a clinician be it an oncologist, nurse or social worker. However, we developed a self-management mobile phone application, ePAL that patients can use in between visits to manage CP. The tool was developed based on clinical guidelines to empower patients for self-management by facilitating patient education, regular pain assessments, and timely feedback, medication changes and improving patient-physician connections. Our strategy is focused on supporting patients by regularly nudging them to assess their level of pain control and coaching them about CP management through regular messaging.Our goal is to help patients with cancer pain gain better control of their symptoms and improve their overall quality of life. Therefore, we hypothesize that patients randomized to receive ePAL will have better pain outcomes, measured by pain intensity, and improved quality of life compared with patients receiving usual care.Our primary aim is to evaluate the effect of ePAL on pain control in patients with cancer pain.Secondary outcomes to be assessed include evaluating the effects of ePAL on: (1) quality of life; (2) hospital utilization for pain crises; (3) adherence to analgesic medications; (4) daily opioid consumption; (5) levels of anxiety; and to evaluate (6) participants’ pattern of engagement with ePAL; and (7) perceived barriers to cancer pain management.This study will be implemented as a 2-arm randomized controlled trial  with repeated assessments at baseline, midpoint, and at the end of the study over an eight weeks follow-up period. Patients must meet all eligibility requirements to be enrolled into the study. Eligible patients are ambulatory, patients aged 18 years or older with diagnoses of a solid-organ cancer and moderate to severe levels  of pain at enrollment. They must also have a mobile phone and should be able to read and speak English. Ineligible patients will be defined as those who (1) have a life expectancy less than two months as determined by the clinical team; (2) have any significant medical or psychiatric comorbidities (other than depression or anxiety) or cognitive impediments that would prevent them from being able to utilize the program; (3) have a known history of substance abuse; and (4) participating in any other investigational therapies or other study protocols that may have an impact on pain intensity or quality of life which are the main outcomes of this study.All patients, regardless of ethnicity, with upcoming appointments at the Massachusetts General Hospital (MGH) Palliative Care Center are considered potential candidates. Therefore, potential subjects for this study will be drawn from adult cancer patients presenting with pain at the MGH Palliative Care Center. They will undergo screening to ensure eligibility and formal enrollment by signing the informed consent form. This is done before any study procedure is carried out. Participating subjects will complete all enrollment surveys and randomization procedures. All participants will be instructed to continue to receive medical care from physicians as usual. Subjects randomized to the intervention arm download the ePAL mobile application and will be taught how to use the functions of the application.The ePAL mobile application was designed to augment existing pain management protocols at the MGH Palliative Care Center and to promote self-efficacy for pain management in patients with cancer pain. Therefore, we use a comprehensive and multimodal approach as recommended by the NCCN guidelines for treatment of adults in addition to addressing common challenges in managing CP, as identified in oncologic clinical practice and in the medical literature . The recPain control is routinely assessed when a patient complains about it during a scheduled visit to the doctor’s office  or during unscheduled patient-initiated visits for uncontrolled pain. ePAL on the other hand, can be easily administered outside of hospital settings. The app prompts participants to assess the level of their pain control over the past 24 hours three times per week. As a result, it provides patients with a medium to regularly evaluate pain control and opportunities for management. Participants with breakthrough pain or other CP-related complaints are able to perform ad hoc pain assessments and management at any time. The app recommends management strategies based on responses to the pain assessment and other pain management barriers. Treatment recommendations are not prescriptive but guide patients on what to do to help them manage their pain. Patients with newly occurring, persistent, or severe pain will be connected directly to the MGH Palliative Care Center for further evaluation and treatment. This is enabled by the automatic call function on the app that links directly to the MGH Palliative Care Center. However, patients have the option to decline speaking with the care team about the trigger symptom. For patients who need further evaluation outside of the regular pain clinic hours, they will be automatically connected with the Palliative Care on-call physician. In addition, participants can pursue medical assistance through the usual emergency phone and paging protocols at the Mass General Palliative Care Center and Cancer Center.Our hope is that by the time patients graduate from the program, at the end of the 2-month study, they will be better equipped to manage their CP in between their clinic visits or appropriately report uncontrolled pain. Contents from the educational library of ePAL will be used to coach participants on pharmacologic and nonpharmacological interventions to reduce CP. Coaching will also address the various misconceptions associated with CP management ,13. PatiThis is one of the key features of the app. Patients are nudged to assess level of their pain control three times per week. However, they are also able to perform ad hoc pain assessments apart from these scheduled prompts. Patients input the level of their pain control on a sliding NRS on the homepage of the ePAL. After patients rate their pain levels, the app will assess whether it is a new or recurring pain, the acceptability or tolerability of the pain, barriers to pain control and also rule out red flag symptoms  that may require further evaluation by the care provider. Based on the identified barriers to adequate pain control, the app then suggests management steps and coaches them by addressing the identified barriers.Patients often report a need for easily accessible and understandable information. For the ePAL mobile app, we developed a comprehensive library with information some of which were created by the investigators and others chosen from reliable sources. The library contains information on a wide array of topics relating to cancer, cancer pain, pain medication, side effects of pain medications, and other related symptoms, barriers to pain management, etc. The library is broken down into topic pages to facilitate users learning at their own pace instead of being overwhelmed by too much information. The app also includes videos  and audio files on relaxation and meditation techniques for pain management.The app offers a diary, directly accessible from the homepage and other relevant locations, for patients to log their experiences dealing with their symptoms and questions they have about their management protocols. This was incorporated into the app based on exploratory needs assessment where some patients reported having lots of questions for their providers which they forget to ask at the clinic visit and leave without hearing the answers. Patients can generate a report of all their notes and bring them up for discussion during the in-person visit. We hope the notes will help the patients better organize their discussions with their care providers during the clinic visits.The app tracks pain scores so that patients can monitor their progress and also share their trends with their care provider and support system. There are two available views: a sliding weekly scale and a monthly calendar view. Pain scores are displayed in green, yellow, and red which correspond to mild, moderate, and severe pain respectively. From here, users can also directly access notes associated with each day.This is an additional feature to bolster user engagement with the app and also to facilitate continuous pain management without the interruption of unfilled prescriptions. This is based on findings from exploratory needs assessment at the MGH Palliative Care Center where patients reported that calling the hospital for refills, pain consultations, appointment scheduling, etc could be stressful and time-consuming. Patients can request refills in one simple tap on the app.Screenshots of the ePAL mobile intervention are shown in Participants will continue to receive medical care from their oncologist, palliative care providers, primary care physicians and other care teams as usual. In addition to usual medical care, they will be able to use ePAL to manage their pain. During the study, intervention subjects will receive push notifications on their phones to assess their pain control over the past 24 hours every morning on Mondays, Wednesdays, and Fridays throughout the study period. The app will guide them through management steps based on their responses. Additionally, one coaching message will be sent to subjects once every day. Subjects will also be encouraged to use the app to manage their pain on-demand, and also to use other features of the app, including pain tracking, prescription refill requests, and the multimedia education library.Participants in the control group will continue to receive medical care from their care teams as usual. However, they will not be able to use the app during the study period.There is one primary outcome and several secondary outcomes that will be assessed in this trial. This study uses several validated instruments for data collection: (1) the Brief Pain Inventory (BPI) assesses participants’ level of cancer pain and interference with daily function ; (2) thePrimary outcome measurement is pain intensity measured as a continuous outcome. It will be measured quantitatively with the BPI that assesses worst, least, average, and current pain intensity over the past week. The self-administered paper version will be used during in-person visits at baseline, midpoint, and at closeout; while the Interactive Voice Response (IVR) version will be used at weeks 2, 4, and 6.To minimize loss of data, any subject who is not able to complete the BPI at weeks 2 and 6 via IVR will be sent REDCap links to complete the surveys online. REDCap is a secure, Web-based application for data collection customizable for individual research studies. It is free and complies with all Health Insurance Portability and Accountability Act regulations (HIPAA). It was developed by a multi-institutional consortium initiated at Vanderbilt University.All secondary outcomes will be assessed at midpoint and at the end of the study. Quality of life will be assessed with the FACT-G and ESAS-r. Hospital utilizations for pain crisis including emergency department or urgent care visits and unplanned clinic visits for pain will be assessed from the Electronic Medical Records. In addition, adherence to analgesic medications will be measured by the MMAS-8; opioid consumption will be measured quantitatively as oral morphine equivalent daily dose; patient-related barriers to pain will be measured quantitatively by the BQ-II; anxiety will be measured by the GAD-7; and pattern of patient engagement with ePAL will be assessed quantitatively by subject’s interaction with the system measured by the number of their responses to interactive messages and the use of other functions such as the notes function on the app.Data will be collected at various time points  as described in t test of difference between means, with 80% power and a 2-sided alpha of .05. Considering a dropout rate of 20%, the sample size required is 110 (55 per group). Fifty-five participants will be randomly assigned to the intervention and the remaining 55 participants will be assigned to the standard practice of care at the MGH Palliative Care Center . Participants will be followed up for a total of 8 weeks.A sample size of 88 subjects, 44 in each arm, is sufficient to detect a clinically important difference of 1.5 between the control and intervention arms in pain intensity scores assuming equal standard deviation of 2.5, using a two-tailed A computer program will be used to randomize subjects into the intervention or control arm in a ratio of 1:1 using random permutated blocks to optimize balance in each treatment at any given point in time during the study. Treatment assignment will be concealed in sealed envelopes prepared by a third party not directly involved with the study. Treatment assignment will be revealed after the consent form has been signed by the study participant. Due to the nature of this study, we will not be able to blind subjects to their treatment assignments. However, treatment assignments will be concealed from the investigators and the data analyst.t test and categorical variables will be compared using chi-square test. All analyses will be based on intention-to-treat in all randomized participants. Our primary outcome, pain intensity, measured longitudinally over eight weeks, will be assessed by mixed model analysis of variance with treatment assignment as between-group factor and time as within-subject factor. Effect sizes will be calculated as mean group differences with standard deviations. A similar approach will be used to analyze continuous secondary outcomes while categorical outcomes will be analyzed by chi-square test.Data analysis will be done with Data Analysis and Statistical Software: STATA, version 13 with an alpha of .05 set a priori for all analyses. All participants will be followed up for eight weeks and we will summarize their baseline demographic and technology use characteristics by study arm. Continuous variables will be compared between control and interventions using the Procedures of our methods have been reviewed and approved by the Dana-Farber/Harvard Cancer Center (DF/HCC) Institutional Review Board (IRB) and the study is registered at . The appPotential candidates with upcoming appointments at the Palliative Care Center will receive a letter informing them about the study. The study consent will also be sent along so that interested candidates can review and ask relevant questions during the enrollment visit. During the study visit, subjects will be given sufficient time to review the consent form and will be encouraged to ask questions. A research assistant will go through the consent form with subjects to ensure they comprehend details of the study. Thereafter, subjects will sign two copies of the consent form–one for them and the other for the study team. Patients who want more time to consider participating in the study will be sent home with an unsigned copy of the consent form and encouraged to think about it at their convenience. Should these patients choose to participate, they will be rescheduled for another enrollment visit. After the informed consent process, the research assistant will then perform all other enrollment procedures.Our expectation is that enabling patients to assess pain control on-demand and empowering them for self-management will lead to improvements in pain and quality of life outcomes. The ePAL mobile application enables patients to assess pain levels, track progression, manage cancer pain and associated symptoms outside hospital settings. Additionally, the app addresses patients’ beliefs that may hinder optimal pain control and also provides an easy way to connect with care providers for timely medication refills. When patients are educated and better understand their cancer and the pain that may be associated with it, improved skills on CP management can be adopted ,14. In aCancer pain, when not managed timely or adequately, may progress to pain crisis necessitating immediate intervention. Pain crisis refers to an episode of severe, uncontrolled pain that causes patients and their caregivers significant distress ,14. EpidA special concern is that the frequent prompts to assess pain control may cause a heightened awareness of symptoms and increase anxiety in some participants. While this is plausible, we hope that the application will increase self-efficacy for self-management. Therefore, the GAD-7 will be useful in establishing the effect of our approach on anxiety. A study by Kroenke and colleagues showed that a telecare management of pain and depression in patients with cancer actually had a positive effect on anxiety levels and was also associated with improvements in pain control and other quality of life outcomes in intervention participants . AnotherGiven that the sample population is drawn from patients attending the palliative care clinic of a large academic center, majority of these patients may have advanced cancers and complicated diseases. As a result, there is a possibility that some patients may not be able to complete the study or attend final study visits. To limit loss to follow-up and missing data, we limit the participation to patients with life expectancy >2 months. Also, we will measure endpoints at multiple times and use REDCap for those unable to attend the final study visit. Another potential limitation is concerning the external validity of the study: This is because findings from this study may be generalizable to patients in academic medical centers. However, if the intervention proves to be effective in these settings, we believe that it will also be effective in patients receiving care in nonacademic medical centers because the app is patient-centered and easily adaptable to other settings.This is one of the first clinical trials evaluating the impact of a multidimensional evidence-based approach to pain management via a mobile phone application. Our hope is that findings from this study could lead to larger, multicenter trials to demonstrate more robust evidence. We also hope that similar evidence-based approaches can be developed for other acute-on-chronic conditions to empower patients for self-care, reduce cost, and improve overall patient outcomes.


Objective. Noncardiac chest pain (NCCP) is seen more frequently in young population and in these patients loss of function is evolving in social and professional areas. The aim of the study is to evaluate the levels of anxiety and somatic perception in patients with chest pain presenting to cardiology clinic. Methods. Fifty-one patients with noncardiac chest pain and 51 healthy controls were included in the study. All participants performed self-report based health anxiety inventory (HAI), somatosensory amplification scale (SAS), and Toronto alexithymia scale (TAS). Results. The patient group had significantly higher scores on the SAS, HAI-1, and HAI-T scales compared to controls . SAS, HAI-1, and HAI-T scores were significantly higher in female patients than male . There were significant differences in all TAS subscale scores between two groups. Patients, who had total TAS score more than 50, also presented higher levels of health anxiety (P = 0.045).  Conclusions. Anxiety, somatic symptoms, and the exaggerated sense of bodily sensations are common in patients with NCCP. These patients unnecessarily occupy the cardiology outpatient clinics. These negative results can be eliminated when consultation-liaison psychiatry evaluates these patients in collaboration with cardiology departments. Chest pain is one of the most common medical complaints in general population. Since it may be a warning sign of coronary artery disease (CAD) or myocardial infarction (MI), it is also one of the most frightening pains , 2. BetwNoncardiac chest pain (NCCP) is defined as a recurrent chest pain that is indistinguishable from ischemic heart pain after a reasonable workup has excluded a cardiac cause. NCCP may report squeezing or burning substernal chest pain, which may radiate to the neck, arms, jaws, and back, and is indistinguishable from cardiac angina . NCCP isDespite a favorable long-term cardiovascular prognosis –15, NCCPDue to the diagnostic classification of NCCP as a “diagnosis” of exclusion  rather than diagnostic inclusion, understanding of this syndrome has been slowed and complicated . Modern Moreover, physicians may be reluctant to ask about the psychological symptoms in these patients, as it has been supposed that patients are defensive about symptoms due to mental illness. The present study was designed to determine the health anxiety level and somatic symptom sensitivity in patients referred to a cardiology clinic for their unexplained chest pain. Our second aim was to examine influences of alexithymia and anxiety sensitivity on chest pain and life interference in patients with NCCP.The investigation complies with the principles outlined in the Declaration of Helsinki. The study was approved by the local ethics committee and all participants gave written informed consent before participating.This study was designed as a case-control study. The study consisted of 59 consecutive outpatients referred for evaluation of chest pain by the stress test at the Marmara University Hospital Department of Cardiology from May 2012 to June 2012. The fact that the referring physician had evaluated the patient's chest pain as sufficiently suspect to necessitate referral for investigation by a cardiologist was taken as adequate for study inclusion. NCCP was defined as a previous study . EligibiResearch assistants identified eligible chest pain patients from cardiology outpatient medical records. The evaluation interview was administered to eligible patients and to control group who consented to participate. The interview included questions about sociodemographic, medical characteristics and psychiatric status. Patients and controls also completed self-reported scales which include health anxiety inventory (HAI), somatosensory amplification scale (SAS), and Toronto alexithymia scale (TAS). The research assistants were trained in the administration of the structured diagnostic interview for mental disorders and supervised by an experienced psychiatrist. The evaluation interviews were audio recorded and 25% of interviews were randomly selected for review to measure interrater agreement on psychiatric status.This brief interview gathered sociodemographic data and general medical history . Hypertension was defined as systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, previously diagnosed hypertension, or use of any antihypertensive medications. Diabetes mellitus was defined as fasting plasma glucose levels more than 126 mg/dL in multiple measurements, previously diagnosed diabetes mellitus or use of antidiabetic medications such as oral antidiabetic agents and insulin. Hyperlipidemia was defined as serum total cholesterol ≥240 mg/dL, serum triglyceride ≥200 mg/dL, low-density lipoprotein cholesterol ≥130 mg/dL, previously diagnosed hyperlipidemia, or use of lipid-lowering medication. Smoking status was defined as the history of tobacco use at admission or in the 6 months prior to visit. Structured Clinical Interview for Diagnostic (SCID-I) and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) [The 18-item self-report HAI measures the intensity of health anxiety especially from the cognitive and emotional perspectives. This easy-to-use self-report scale can be used in patients with medical disorders as well as psychiatric patients. HAI has fourteen items to enquire psychological status of the patients  and its last four items to carry out the data about psychology of the patients if they have a serious illness . HAI-T score is the total score of the HAI-1 and HAI-2 subscales. All items are rated on a 0- to 3-point Likert scale and ratings are summed to produce a total score that ranges from 0 to 54. The Turkish version of HAI has adequate reliability and validity in clinical and nonclinical samples .The 10-item self-report SAS measures how the physical symptoms are experienced by patients and their susceptibility to the somatization. This scale is applicable to the patients with psychiatric or medical disorders and also to the healthy community. All items are rated on a 1- to 5-point Likert scale and ratings are summed to produce a total score that ranges from 10 to 50. The Turkish version of SAS has adequate reliability and validity in clinical and nonclinical samples  .Alexithymia was measured using the 20-item self-report TAS . All itet-test and the Mann-Whitney U-test were used for comparison of parametric and nonparametric variables between patient and control groups. Significance level was set at P < 0.05.Statistical analyses were performed using SPSS 16.0 statistical package for Windows. Distribution of data was assessed by using one-sample Kolmogorov-Smirnov test. Continuous data were expressed as mean ± standard deviation while categorical data were presented as a number and percentage of patients. Chi-square test was used for comparison of categorical variables. Student's P < 0.001). The prevalence of smokers in patient and control groups was estimated to be 41.2% and 5.9%, respectively (P < 0.001). Control group had significantly higher rates of working status than those of patient group (P < 0.001). There were no significant differences in cardiac risk factors associated with cardiovascular disease like hypertension, hyperlipidemia, and diabetes mellitus. The patient and control groups were compatible with each other according to the medical history.Sociodemographic characteristics for the two groups are presented in P < 0.001), HAI-T (P < 0.05), and HAI-1 (P = 0.006) scales. As indicated in P = 0.002) and higher health anxiety level on HAI-1 (P = 0.036) and HAI-T (P = 0.039) scales. P = 0.016), difficulty describing feelings (DDF) (P = 0.005), and externally oriented thinking (EOT) (P = 0.002). As indicated in P = 0.045). There was no relationship between alexithymia and health anxiety levels in control group.Being consistent with our first hypothesis, health anxiety and somatosensory sensitivity were associated with higher referral to the cardiology clinics for NCCP. Somatosensory sensitivity and health anxiety level, as anticipated, was positively associated with healthcare utilization and life interference from chest pain ; howeverOur first findings largely congruent with theoretical models of NCCP show that personality and emotional factors are important in this medically unexplained syndrome , 23, 25.Depression and anxiety are common in patients with CAD. In a recent study, we demonstrated a significant relationship between depression and anxiety scores and CAD while cardiovascular risk factors were similar between patient and control groups . PsycholOur results suggest that health anxiety sensitivity, somatosensory sensitivity, and alexithymia may be important psychological factors in the etiology and maintenance of NCCP. Within the alexithymia texture, greater difficulty identifying and describing feelings were associated with higher health anxiety. This finding is consistent with other empirical research demonstrating that NCCP individuals, who misperceive or are unable to verbally express affect-related bodily sensations and therefore report fewer or less intense emotional experiences, report more severe cardiac related physical sensations , 17. SomThese results need replication in light of study limitations. In the meantime few studies have particularly examined patients with NCCP, and the present study contributes to the growing body of literature on this disorder. However, relatively small sample size and the use of a specific patient population may limit the generalizability of these findings. This study is also limited by the possibility of shared method variance. As these results relied on self-report data, this may be especially problematic for conclusions concerning alexithymia. Since alexithymia implies limited awareness of internal psychology, the appropriateness of assessing it through self-report measure may be somewhat paradoxical; that is, in the diminished ability to identify and describe affect, individuals may have difficulty completing self-report measures , 25, 29.The NCCP syndrome has long been frustrating for the medical community. Anxiety sensitivity and alexithymia appear to represent a specific psychological vulnerability factor that would benefit from specialized psychological interventions. Research exploring the risk and resilience factors that contribute to the syndrome of NCCP is necessary in order to identify the best ways to intervene for each individual.


The aim of this study was to determine the effect of sodium bicarbonate irrigation versus normal saline irrigation in patients undergoing a laparoscopic cholecystectomy. Pain in patients undergoing laparoscopic cholecystectomy is the most common complaint, especially in the abdomen, back, and shoulder region. In a double blind randomized clinical trial, 150 patients were assigned to the three groups (50 patients in each group). Group A received intraperitoneal irrigation normal saline (NS). Groups B and C received irrigation sodium bicarbonate and none irrigation, respectively. Pain was assessed using a visual analog scale (VAS) for 6, 18 and 24 hours postoperatively, as well as one week after the surgery. Data analysis was performed using SPSS ver18 and chi-square, Fisher’s Exact Test, on-way ANOVA and repeated measure ANOVA tests. Patients in groups showed no significant difference in terms of age, gender, past medical history and smoking history (p>0.05). Left shoulder tip pain was significantly lower only between the sodium bicarbonate group and non-washing group at 6, 18, and 24 hours postoperatively . There was no significant difference between the three treatment groups in right shoulder tip pain, back pain and port site incisional pain.  In laparoscopic cholecystectomy, peritoneal irrigation with sodium bicarbonate may reduce the intensity of postoperative shoulder tip pain and is an effective method for improving the quality of life within the early recovery period.  Laparoscopic cholecystectomy is considered as the treatment of choice for symptomatic cholelithiasis . Laparos2 and phrenic nerve irritation in the peritoneal cavity  and narcotics, gas drainages, intraperitoneal saline and intraperitoneal of local anesthetics and opioids were carried out to reduce pain after a laparoscopic cholecystectomy. While, use of these methods for pain relief after laparoscopic cholecystectomy had a lot of side effects or was not associated with a similar result , 14-17. 2 insufflation) using peritoneal wash out with sodium bicarbonate . This randomized clinical trial was designed to determine whether it is possible to reduce post laparoscopic pain by neutralizing acidic peritoneal environment , which was done from September 2012 to September 2014. After approval of the local ethics committee, 150 patients  of ASA physical status I-II undergoing elective laparoscopic cholecystectomy were prospectively randomized (with permutation block randomization) into 3 groups with concealment of the random group. Exclusion criteria were positive history of the use of opioids, steroids, NSAIDs and alcohol. Also, patients with acute cholecystitis, gangrene or empyema of the gallbladder, conversion to an open procedure for any reason, rupture of the gallbladder and bile leakage at the site of surgery, and bleeding in the site of surgery that could cause the peritoneal irritation were excluded. Demographic data, including age, gender, past medical history, smoking history and time of pneumoperitoneum was recorded.2 through a periumbilical trocar, and was maintained at 14mm Hg during the entire surgical procedure. After removal of the gallbladder, hemostasis was performed in the surgical bed, and patients were randomly assigned to each of the three groups of 50 patients: All patients were referred to the operating room without premedication. A standard anesthetic was used during surgery. All laparoscopic cholecystectomy were performed by the same surgeon. A standard operative method was used with a 4-trocar technique in all patients. Nasogastric tube was inserted for all patients after intubation and was removed at the end of the surgery. Pneumoperitoneum was achieved with insufflations of COGroup A, normal saline group: 1000 ml normal saline 0.9%at a temperature of 37ْC was infused in the surgical bed, superior surface of the liver and under the right hemi diaphragm. Group B, sodium bicarbonate group: 50 ml sodium bicarbonate 7.5% in 1000 ml normal saline at a temperature of 37ْC was infused in the surgical bed, superior surface of the liver and under the right hemi diaphragm. Group C, non-washing group: no intraperitoneal irrigation was applied. 2 was carefully evacuated at the end of the surgery by manual compression of the abdomen with open trocars . No drains were used. Pain was assessed during an interview with the patients using a visual analog scale (VAS) of 0 to 10 by a trained interviewer unaware of the grouping of patients. During an interview, the interviewer explained the VAS for every patient, defining “0” for ‘no pain’ and “10” for ‘the worse imaginable pain’.In normal saline and bicarbonate groups, the fluid was completely aspirated before the pneumoperitoneum was deflated. COAssessments were done at the patient’s bedside at 6, 18 and 24 hours postoperatively, as well as a week after the surgery (in the first postoperative visit). Intensity of pain was recorded at 8 locations for assessment of port site incision pain, shoulder tip pain and back pain, including 3 port site incisions (port site incision pain), each of shoulder tips (shoulder tip pain) and the area between the shoulders and the tip of scapulas (Back pain).During the first 24 hours after the surgery, all of the patients were allowed to receive Paracetamol as analgesic as needed , and the exact times of administrations were recorded in the patients’ files in special tables for the study. Data were entered into a data bank using SPSS ver. 18. In addition to descriptive tables, in the analysis of the data we used chi-square, Fisher’s Exact Test, one-way ANOVA and repeated measure ANOVA. The statistical level of significance was set at P<0.05.One hundred and fifty patients were enrolled into the study, 50 in each group. No significant difference was found between the 3 groups in terms of demographic data including: sex and age distribution, as well as past medical history , and smoking history . There wThere was no significant difference in the average time of pneumoperitoneum in sodium bicarbonate group and two other groups . In our patients, the most painful site was the site of umbilical incision , followed by pain at other trocar sites and the shoulder tips. The area between the shoulders and under the scapulas had the lowest pain intensity . Very fePort site incisional painIn the evaluation of port site incisional pain, there was no statistically significant difference between the three treatment groups in ANOVA tests .Shoulder tip painComparison of shoulder tip pain with repeated measure analysis of variance showed that, overall pain intensity of left shoulder was significantly different between the three treatment groups. The sodium bicarbonate group had significantly less overall pain intensity than non-washing group . Also change of pain intensity over the time was different between the 3 groups. Decrease of left shoulder tip pain over the time was more in sodium bicarbonate group in comparison with non-washing group  . CompariIn the evaluation of the right shoulder tip pain, despite the fact that pain intensity of the sodium bicarbonate group was less than other two groups in almost all of the time points, there was no statistically significant difference in ANOVA tests .Analysis using repeated measure ANOVA showed that there was no significant difference in the mean pain intensity of shoulders between the three groups  there was no significant difference between the 3 treatment groups in ANOVA tests (figure 3).Postoperative analgesic requirementRegarding the number of analgesia demand over the 24 hours postoperatively, ANOVA tests showed no significant difference between the 3 treatment groups . 2 insufflation constitutes the commonest means of creating the pneumoperitoneum. CO2 pneumoperitoneum is known to cause systemic acidosis (2 laparoscopy (2 gas was used for pneumoperitoneum, it was shown that the intraperitoneal pH was 6.0 immediately after the operation and raised to 6.4–6.7 and 6.8–6.9 on the first and second post-operation days, respectively (2 (Despite many advances in laparoscopic cholecystectomy, postoperative pain is still a serious problem, and in most reports, up to 80% of patients ask for analgesics after laparoscopic cholecystectomy . Pain inacidosis . Recent aroscopy -24. In oectively . Peritonectively . Moreoveively (2 . Both ofAs you can see in 2 gas above the liver, but sodium bicarbonate neutralizes the acidic sub diaphragmatic area more effective than saline solution that leads to less diaphragmatic and peritoneal irritation, as well as less postoperative pain.In previous studies that used sub diaphragmatic washout with saline solution, a significant decrease in postoperative pain intensity has been reported , 27. In In previous studies, which used intraperitoneal bupivacaine washout for reduction of pain after laparoscopic cholecystectomy, the effect was short-lived and did not exceed 6-12 hours after the surgery , 29. In The limitation of this study was the lack of integration groups in terms of age and sex. We recommend clinical trials studies with considering these factors due to effect of them on pain . Intraperitoneal irrigation of sodium bicarbonate is a simple and safe method that provides pain relief in the postoperative period after laparoscopic cholecystectomy compared with none-washing. Also, intraperitoneal irrigation of sodium bicarbonate was found to have a better pain relief profile compared with normal saline. We recommend that the sodium bicarbonate washout procedure to be used at laparoscopic cholecystectomy, because it is a way for reducing the post laparoscopic pain intensity for 24h after surgery.


Background & Aims. Chronic pancreatitis (CP) is often associated with abdominal pain, which impairs quality of life. The aim of this prospective study was to clarify whether the use of a low-fat elemental diet (ED) is beneficial for managing pain in patients with CP. Methods. Seventeen CP patients with pain despite fat-restricted dietary and conventional medical treatments were enrolled in this prospective study. These patients received low-fat ED therapy in addition to restricting fat intake for 8 weeks. The change of pain severity was examined by interviewing the patient and status of analgesic use. Results. Mean serum levels of amylase and lipase at 8 weeks after the beginning of low-fat ED therapy decreased compared to those before the therapy. At 8 weeks, pain alleviation after low-fat ED therapy was reported in 15 out of 17 patients (88%). Of these 15 patients, 10 patients reported complete pain disappearance. One of 3 patients with severe or moderate pain requiring analgesic was relieved of analgesic use after low-fat ED therapy. Conclusion. Low-fat ED therapy is useful as means of pain control in CP. The therapy is recommended in outpatients with CP who present with pain despite conventional dietary and medical treatments. Chronic pancreatitis (CP) is characterized histologically by the destruction of acinar cells and presence of irregular fibrosis within the pancreas. Most patients with CP have abdominal pain, maldigestion, and diabetes mellitus , 2. The It is well known that an elemental diet (ED) has a protective effect in patients suffering from Crohn's disease . ED has To the best of our knowledge, no additional survey has confirmed the utility of low-fat ED therapy in CP patients with pain. The aim of this prospective study was to clarify whether the use of a low-fat ED is beneficial for managing pain in patients with CP. N-benzoyl-L-tyrosyl-p-aminobenzoic acid test) ..10]. ThePain severity was assessed at 0 weeks (at the beginning of the low-fat ED therapy) and at 4 and 8 weeks (after the initiation of therapy) by performing patient interviews and assessing the status of analgesic use. Pain degree was graded according to 3 levels as follows: grade 2, severe or moderate pain requiring analgesics; grade 1, mild pain not requiring analgesics; and grade 0, no pain. Moreover, we determined the serum levels of amylase, lipase, total protein, and albumin and evaluated the adverse events at 0, 4, and 8 weeks.CP was classified into 2 distinct categories according to etiology: alcoholic and nonalcoholic. Alcoholic CP was diagnosed in patients with a daily intake of pure alcohol >80 g for at least 5 years. Nonalcoholic CP included idiopathic CP and CP induced by other etiological factors, including neoplasm and congenital anomaly . The diat-test for quantitative variables. A P value <0.05 was considered statistically significant.Differences among groups were analyzed using Student's Nineteen patients with CP were prospectively registered in this study. However, 2 patients were excluded from the study: 1 patient with diabetes showed aggravated glycemic control at 4 weeks after the initiation of ED therapy, and another patient was lost to follow-up. Accordingly, a total of 17 patients  were studied . AlcoholMean serum levels of amylase and lipase at 8 weeks after low-fat ED therapy decreased compared to those at 0 weeks , but the differences were not significant .At 8 weeks, pain alleviation after the low-fat ED therapy was reported in 15 of 17 patients (88%). Of these 15 patients, 10 patients reported complete pain disappearance. One of 2 patients whose pain did not improve had calcified CP accompanied with pancreatic atrophy indicative of the so-called late-stage CP. No patient experienced pain exacerbation after the low-fat ED therapy. The evaluation of pain using pain grades at 0, 4, and 8 weeks is shown in Patients' mean serum levels of total protein and albumin at 8 weeks did not differ significantly from those at 0 weeks .CP is often associated with recurrent or protracted pain that impairs quality of life –3. The pED is a digested nutritional supplement that consists of amino acids, dextrin or glucose, and minimal fat. A few reports have shown that ED was useful in the management of pancreatitis since it is less simulating to the pancreas , 17, 18.Enteral nutrition therapy using ED was reported to have supportive effects in patients with Crohn's disease, including the remission of active disease, maintaining the remission of quiescent disease, and preventing postoperative recurrence , 19. TheNutrition support is considered important in the management of CP because patients suffering from CP sometimes experience maldigestion due to pancreatic exocrine insufficiency resulting from ongoing pancreatic destruction . AnotherIto et al. reported 2 cases of calcified CP with repeated pain episodes that could be alleviated using low-fat ED therapy . In thisTo date, several attempts have been made to evaluate the degree of pain in CP using different pain scales and protocols  , 29. HowLow-fat ED therapy is safe and simple. However, a patient suffering from diabetes had to abandon ED therapy at 4 weeks due to aggravated glycemic control. Particular attention is needed when administering ED therapy to patients with CP and diabetes.In summary, low-fat ED therapy might be useful for pain management of outpatients with CP when patients experience acute and recurring pain attacks. The results of this study need to be confirmed by a randomized study comparing pain control responses between patients with CP who are or are not treated with low-fat ED therapy.