Effect of high doses of sodium bicarbonate in acute organophosphorous pesticide poisoning. Pralidoxime in acute organophosphorus insecticide poisoning--a randomised controlled trial. Haematoma block or Bier's block for Colles' fracture reduction in the accident and emergency department--which is best? Alkalinisation of lignocaine to reduce the pain of digital nerve blockade. Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial. Volume guarantee: stability of tidal volume and incidence of hypocarbia. Nettle sting for chronic knee pain: a randomised controlled pilot study. Influence of pesticide regulation on acute poisoning deaths in Sri Lanka. Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis. Effects of high volume saline enemas vs no enema during labour--The N-Ma Randomised Controlled Trial [ISRCTN43153145]. Biochemical and clinical profile after organophosphorus poisoning--a placebo-controlled trial using pralidoxime.
The sodium bicarbonate (NaHCO3) dosage used in treating the patients with organophosphorous pesticide (OP) poisoning did not result in sufficient alkalinization of the blood. We thus investigated the effects of higher doses by infusion (5 mEq/kg over 1 hour, followed by 5-6 mEq/kg daily until recovery or death) to maintain the arterial pH between 7.45 and 7.55. There were 26 (14 M and 12 F) patients aged 24.1 +/- 9.7 years and 27 (16 M and 11 F) aged 25.7 +/- 9.1 years in the test and contro groups, respectively. Arterial blood pH of the test group (7.48 +/- 0.02) was much higher (p < 0.0001) than the controls (7.36 +/- 0.02). The total atropine doses used for the control patients (129.45 +/- 61 mg) was significantly (p = 0.048) higher than the controls (93.4 +/- 59.1 mg). Hospitalization days were statistically higher (p = 0.037) in the controls (5.59 +/- 1.97 days) than in the bicarbonate group (4.33 +/- 1.99 days). Infusion of high doses of NaHCO3 appears to be beneficial in treatment of patients with OP poisoning. Poisoning with organophosphorus (OP) insecticides is a major global public health problem, causing an estimated 200,000 deaths each year. Although the World Health Organization recommends use of pralidoxime, this antidote's effectiveness remains unclear. We aimed to determine whether the addition of pralidoxime chloride to atropine and supportive care offers benefit.
                We performed a double-blind randomised placebo-controlled trial of pralidoxime chloride (2 g loading dose over 20 min, followed by a constant infusion of 0.5 g/h for up to 7 d) versus saline in patients with organophosphorus insecticide self-poisoning. Mortality was the primary outcome; secondary outcomes included intubation, duration of intubation, and time to death. We measured baseline markers of exposure and pharmacodynamic markers of response to aid interpretation of clinical outcomes. Two hundred thirty-five patients were randomised to receive pralidoxime (121) or saline placebo (114). Pralidoxime produced substantial and moderate red cell acetylcholinesterase reactivation in patients poisoned by diethyl and dimethyl compounds, respectively. Mortality was nonsignificantly higher in patients receiving pralidoxime: 30/121 (24.8%) receiving pralidoxime died, compared with 18/114 (15.8%) receiving placebo (adjusted hazard ratio [HR] 1.69, 95% confidence interval [CI] 0.88-3.26, p = 0.12). Incorporating the baseline amount of acetylcholinesterase already aged and plasma OP concentration into the analysis increased the HR for patients receiving pralidoxime compared to placebo, further decreasing the likelihood that pralidoxime is beneficial. The need for intubation was similar in both groups (pralidoxime 26/121 [21.5%], placebo 24/114 [21.1%], adjusted HR 1.27 [95% CI 0.71-2.29]). To reduce confounding due to ingestion of different insecticides, we further analysed patients with confirmed chlorpyrifos or dimethoate poisoning alone, finding no evidence of benefit.
                Despite clear reactivation of red cell acetylcholinesterase in diethyl organophosphorus pesticide poisoned patients, we found no evidence that this regimen improves survival or reduces need for intubation in patients with organophosphorus insecticide poisoning. The reason for this failure to benefit patients was not apparent. Further studies of different dose regimens or different oximes are required. To offer clear guidance on the anaesthetic management of Colles' fractures in the accident and emergency (A&E) department in the light of the conflict between existing reports and current trends, and to address the issue of alkalinisation of haematoma blocks.
                This was a two centre, prospective, randomised clinical trial with consecutive recruitment of adult patients with Colles' fractures requiring manipulation to receive either Bier's block or haematoma block. There was subsequent blinded randomisation to alkalinised or non-alkalinised haematoma block.
                72 patients were recruited into the Bier's block group, and 70 into the haematoma block group. Bier's block was less painful to give than the haematoma block (median pain score 2.8 v 5.3; P < 0.001), and fracture manipulation was also less painful in the Bier's block group (median pain score 1.5 v 3.0; P < 0.01). There was no significant difference in overall A&E transit time between the two groups. There was better initial radiological outcome in terms of dorsal angulation in the Bier's block group (-3.6 degrees v 2.1 degrees; P = 0.003). More remanipulations were required in the haematoma block group (17/70 v 4/72; P = 0.003). There was a trend towards decreased pain on administration of the alkalinised haematoma block when compared with non-alkalinised haematoma block, but this did not reach significance. There was no difference in pain score on fracture manipulation. There were no complications in either group.
                Bier's block is superior to haematoma block in terms of efficacy, radiological result, and remanipulation rate; transit times are equal, both procedures are practical in the A&E environment, and there were no complications. Bier's block is the anaesthetic management of choice for Colles' fractures requiring manipulation within the A&E department. To see if the alkalinisation of lignocaine caused a reduction in the pain of injection for digital nerve blockade.
                The study was a prospective randomised double blind study with each patient acting as their own control. During the study period, all patients aged 16 years and over presenting to the accident and emergency department with a condition requiring digital nerve blockade were considered for inclusion in the study. Each patient received an injection of both alkalinised and non-alkalinised lignocaine. The pain of each injection was then assessed on a visual analogue scale.
                98 patients were entered in the study. The mean difference in pain scores between the non-alkalinised and alkalinised injections was 0.739, P < 0.001, 95% confidence interval 0.47 to 1.01.
                Alkalinisation of lignocaine reduces the pain of injection for digital nerve blockade. Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme. Excessive tidal volume (V(T)) can lead to lung injury, hypocarbia, and neurologic damage. Volume guarantee (VG) uses exhaled V(T) as the control variable to reduce the risk of volutrauma and more closely control PaCO(2). Our objective was to test the hypothesis that VG combined with assist/control (A/C) will maintain PaCO(2) and V(T) within target range more consistently than assist/control alone during the first 72 hr of life in ventilated preterm infants. Eligible infants were randomly assigned to A/C + VG or A/C alone. Data were recorded directly from the pressure and volume module of the Draeger Babylog 8000+ ventilator. Arterial blood gases were obtained every 2-6 hr, as clinically indicated. In A/C, inspiratory pressure was adjusted to achieve a V(T) of 4-6 ml/kg. In VG, the target V(T) was 5 ml/kg. Subsequent adjustments were made by the clinical team in response to arterial blood gas measurements (ABG). Proportion of breaths and PaCO(2) values outside the target range were compared by chi(2), and continuous variables by t-test. There were no differences in demographic or baseline ventilator variables between the 18 infants in the two groups. For 1,805/11,950 breaths (15.1%), V(T) was > target with A/C + VG, vs. 2,503/9,853 (25.4%) with A/C (P < 0.001). V(T) was < target for 21.7% of breaths with A/C + VG, vs. 35.7% with A/C (P < 0.001). Twenty percent of PaCO(2) values were < target, with A/C + VG vs. 36.3% with A/C, P < 0.05. The proportion of PaCO(2) values > target was similar in the two groups. Oxygenation and mean pH were not different. No complications related to mechanical ventilation were observed. In conclusion, VG significantly reduced hypocarbia and excessively large V(T). This suggests the potential to reduce pulmonary and neurologic complications of mechanical ventilation. Larger studies are needed to establish safety and demonstrate such benefits.
                Copyright 2004 Wiley-Liss, Inc. Non-pharmacological interventions for chronic knee pain are increasingly requested by patients and are recommended in current treatment guidelines. An intervention that has been used for many years for pain relief is nettle sting.
                To explore the feasibility of a definitive RCT of nettle sting for chronic knee pain, in particular the acceptability of the research to GPs and patients, and the optimal methods for recruitment and outcome measurement.
                Patient blinded pilot RCT, set in two inner city primary care practices in Plymouth, UK. Potential participants were identified from practice computerised databases using three different approaches: age and analgesic use, age and appropriate Read code, or age alone. Patients had to be aged between 55 and 80 years with knee pain and a presumptive clinical diagnosis of OA knee, with a baseline WOMAC pain subscale score of more than 4. They were randomised to receive either treatment with Urtica dioica, or placebo intervention with Urtica galeopsifolia daily for 1 week. The main outcome measure for the treatment effect was the WOMAC pain subscale; other outcomes included quantitative and qualitative data to inform the design of a future study.
                Out of 45 patients who were eligible, 42 were recruited. Invitations targeted at patients who were both currently receiving repeat prescriptions for non-steroidal or analgesic drugs and had relevant Read codes proved most efficient for recruitment. Mean baseline WOMAC pain subscale scores were 9.2 (S.D. 3.4) and 7.9 (2.3) in the two groups. The mean reduction in pain score at the end of treatment in the nettles group was 1.7 (95% confidence interval 0.6, 2.9) and in the controls 1.6 (CI 0.5, 2.7). All GP practices, and all patients approached, were willing to be involved in the research. Patients liked the treatment mostly because it was 'natural'. The sting was acceptable and viewed as a minor irritation.
                Research into nettle sting is acceptable to patients and GPs, and patients do not find the treatment more than a minor irritation. Larger rigorous studies are justified to determine the effectiveness of this ancient therapy. To assess in a developing Asian country the impact of pesticide regulation on the number of deaths from poisoning. These regulations, which were implemented in Sri Lanka from the 1970s, aimed to reduce the number of deaths - the majority from self-poisoning - by limiting the availability and use of highly toxic pesticides.
                Information on legislative changes was obtained from the Ministry of Agriculture, national and district hospital admission data were obtained from the Sri Lanka Health Statistics Unit, and individual details of deaths by pesticide poisoning were obtained from a manual review of patients' notes and intensive care unit records in Anuradhapura.
                Between 1986 and 2000, the total national number of admissions due to poisoning doubled, and admissions due to pesticide poisoning increased by more than 50%. At the same time, the case fatality proportion (CFP) fell for total poisonings and for poisonings due to pesticides. In 1991_92, 72% of pesticide-induced deaths in Anuradhapura were caused by organophosphorus (OP) and carbamate pesticides - in particular, the WHO class I OPs monocrotophos and methamidophos. From 1991, the import of these pesticides was reduced gradually until they were banned for routine use in January 1995, with a corresponding fall in deaths. Unfortunately, their place in agricultural practice was taken by the WHO class II organochlorine endosulfan, which led to a rise in deaths from status epilepticus - from one in 1994 to 50 in 1998. Endosulfan was banned in 1998, and over the following three years the number of endosulfan deaths fell to three. However, at the end of the decade, the number of deaths from pesticides was at a similar level to that of 1991, with WHO class II OPs causing the most deaths. Although these drugs are less toxic than class I OPs, the management of class II OPs remains difficult because they are, nevertheless, still highly toxic, and their toxicity is exacerbated by the paucity of available facilities.
                The fall in CFP amidst a rising incidence of self-poisoning suggests that Sri Lanka's programmes of pesticide regulation were beneficial. However, a closer inspection of pesticide-induced deaths in one hospital revealed switching to other highly toxic pesticides, as one was banned and replaced in agricultural practice by another. Future regulation must predict this switching and bear in mind the ease of treatment of replacement pesticides. Furthermore, such regulations must be implemented alongside other strategies, such as integrated pest management, to reduce the overall pesticide availability for self-harm. To determine the efficacy of community water-based therapy for the management of lower limb osteoarthritis (OA) in older patients.
                A pre-experimental matched-control study was used to estimate efficacy of water-based exercise treatment, to check design assumptions and delivery processes. The main study was a randomised controlled trial of the effectiveness of water-based exercise (treatment) compared with usual care (control) in older patients with hip and/or knee OA. The latter was accompanied by an economic evaluation comparing societal costs and consequences of the two treatments.
                Water exercise was delivered in public swimming pools in the UK. Physical function assessments were carried out in established laboratory settings.
                106 patients (93 women, 13 men) over the age of 60 years with confirmed hip and/or knee OA took part in the preliminary study. A similar, but larger, group of 312 patients (196 women, 116 men) took part in the main study, randomised into control (159) and water exercise (153) groups.
                Control group patients received usual care with quarterly semi-structured telephone interview follow-up only. The intervention in the main study lasted for 1 year, with a further follow-up period of 6 months.
                Pain score on the Western Ontario and McMaster Universities OA index (WOMAC). Additional outcome measures were included to evaluate effects on quality of life, cost-effectiveness and physical function measurements.
                Short-term efficacy of water exercise in the management of lower limb OA was confirmed, with effect sizes ranging from 0.44 [95% confidence interval (CI) 0.03 to 0.85] on WOMAC pain to 0.76 (95% CI 0.33 to 1.17) on WOMAC physical function. Of 153 patients randomised to treatment, 82 (53.5%) were estimated to have complied satisfactorily with their treatment at the 1-year point. This had declined to 28 (18%) by the end of the 6-month follow-up period, during which support for the intervention had been removed and those wishing to continue exercise had to pay their own costs for maintaining their exercise treatment. High levels of co-morbidity were recorded in both groups. Nearly two thirds of all patients had a significant other illness in addition to their OA. Fifty-four control and 53 exercise patients had hospital inpatient episodes during the study period. Water exercise remained effective in the main study but overall effect size was small, on WOMAC pain at 1 year, a reduction of about 10% in group mean pain score. This had declined, and was non-significant, at 18 months. Mean cost difference estimates showed a saving in the water exercise group of pound123--175 per patient per annum and incremental cost-effectiveness ratios ranged from pound3838 to pound5951 per quality-adjusted life-year (QALY). Net reduction in pain was achieved at a net saving of pound135--175 per patient per annum and the ceiling valuation of pound580--740 per unit of WOMAC pain reduction was favourably low.
                Group-based exercise in water over 1 year can produce significant reduction in pain and improvement in physical function in older adults with lower limb OA, and may be a useful adjunct in the management of hip and/or knee OA. The water-exercise programme produced a favourable cost--benefit outcome, using reduction in WOMAC pain as the measure of benefit. Further research is suggested into other similar public health interventions. Investigation is also needed into how general practice can best be supported to facilitate access to participants for research trials in healthcare, as well as an examination of the infrastructure and workforce capacities for physical activity delivery and the potential extent to which healthcare may be supported in this way. More detailed research is required to develop a better understanding of the types of exercise that will work for the different biomechanical subtypes of knee and hip OA and investigation is needed on access and environmental issues for physical activity programmes for older people, from both a provider and a participant perspective, the societal costs of the different approaches to the management of OA and longer term trends in outcome measures (costs and effects). Enemas are used during labour in obstetric settings with the belief that they reduce puerperal and neonatal infections, shorten labour duration, and make delivery cleaner for attending personnel. However, a systematic review of the literature found insufficient evidence to support the use of enemas. The objective of this RCT was to address an identified knowledge gap by determining the effect of routine enemas used during the first stage of labour on puerperal and neonatal infection rates.
                
                RCT (randomised controlled trial; randomized clinical trial).
                Clinical diagnosis of maternal or neonatal infections, labour duration, delivery types, episiotomy rates, and prescription of antibiotics.
                Tertiary care referral hospital at the Javeriana University (Bogotá, Colombia) that attended 3170 births during study period with a caesarean section rate of 26%.
                443 women admitted for delivery to the obstetrics service (February 1997 to February 1998) and followed for a month after delivery. Inclusion criteria were women with: low risk pregnancy and expected to remain in Bogotá during follow up; gestational age > or = 36 weeks; no pelvic or systemic bacterial infection; intact membranes; cervix dilatation < or = 7 cm.
                1 litre saline enema, versus no enema, allocated following a block random allocation sequence and using sealed opaque envelopes.
                Allocation provided balanced groups and 86% of the participants were followed up for one month. The overall infection rate for newborns was 21%, and 18% for women. We found no significant differences in puerperal or neonatal infection rates (Puerperal infection: 41/190 [22%] with enema v 26/182 [14%] without enema; RR 0.66 CI 95%: 0.43 to 1.03; neonatal infection 38/191 [20%] with enema v 40/179 [22%] without enema; RR 1.12, 95% CI 95% 0.76 to 1.66), and median labour time was similar between groups (515 min. with enema v 585 min. without enema; P = 0.24). Enemas didn't significantly change episiorraphy dehiscence rates (21/182 [12%] with enema v 32/190 [17%] without enema; P = 0.30).
                This RCT found no evidence to support routine use of enemas during labour. Although these results cannot rule out a small clinical effect, it seems unlikely that enemas will improve maternal and neonatal outcomes and provide an overall benefit. Organophosphorus (OP) compounds are the most common suicidal poison in developing countries and mortality continues to be high.
                A study was done to see butyryl cholinesterase (BuChE) profile after OP poisoning in pralidoxime (P2AM) and placebo treated cases. Highest recommended dose of P2AM was used to study the reactivation of cholinesterase. Clinical outcomes like, correlation of BuChE and severity of poisoning, mortality and complications like Type I and II paralysis, need for ventilation and ICU stay were also studied.
                Twenty one cases of moderate and severe poisoning with OP compounds were included in the study. Mean BuChE levels came up gradually over 6-7 days, some taking up to two weeks. There was no. difference between the treatment and placebo groups. BuChE levels did not correlate with severity of poisoning nor did it correlate with Type I or II paralysis, need for ventilation, ICU stay or mortality.
                Treatment with P2AM does not make any difference in BuChE reactivation or complications of moderate and severe OP poisoning. We have not been using P2AM for OP poisoning in our medical ICU with good patient outcomes.
Preliminary studies suggest benefit from blood alkalinisation with NaHCO3 in OP poisoning, but there is insufficient evidence to support its routine clinical use. Further research is required to determine the method of alkalinisation that will optimise outcomes, and the regimen which will produce the target arterial pH of 7.50 (range 7.45 to 7.55). This should be followed by a well-designed randomised controlled trial to determine efficacy.