Antiemetic efficacy of a droperidol-morphine combination in patient-controlled analgesia. Randomized, double-blind trial of dolasetron versus droperidol for prophylaxis of postoperative nausea and vomiting in patients undergoing TRAM flap breast reconstruction surgery. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. Droperidol-supplemented anaesthesia decreases post-operative nausea and vomiting but impairs post-operative mood and well-being. Treating "rebound" emesis following outpatient gynecologic laparoscopy: the efficacy of a two-dose regimen of droperidol and ondansetron. Prevention of emesis after strabismus repair in children: a prospective, double-blinded, randomized comparison of droperidol versus ondansetron. Menstruation increases the risk of nausea and vomiting after laparoscopy. A prospective randomized study. ParaSight-F test to diagnose malaria in hypo-endemic and epidemic prone regions of Vietnam. Randomized clinical trial comparing intravenous midazolam and droperidol for sedation of the acutely agitated patient in the emergency department. Comparison of ondansetron and droperidol in the prevention of postoperative nausea and vomiting after laparoscopic surgery in women. A randomised, double-blind, placebo-controlled trial. A controlled clinical trial of oral droperidol and droperidol plus diazepam for premedication in children.
To evaluate the antiemetic effectiveness and side effects of adding low-dose droperidol to morphine delivered via a patient-controlled analgesia (PCA) device.
                Randomized, double-blind, clinical study.
                University-affiliated women's hospital.
                60 healthy women, 18 to 60 years of age, who underwent total abdominal hysterectomy with a standardized anesthetic regime.
                After surgery, the control group (n = 20) had access via PCA to two cartridges, each containing morphine 1 mg/ml and saline 1 ml. The two treated groups (n = 20 each) had access via PCA to either droperidol 0.5 mg or droperidol 1 mg added to two cartridges containing morphine 1 mg/ml.
                Preoperative data, including each patient's history of nausea and vomiting with and without previous anesthesia, motion sickness, smoking, and alcohol intake, and date of her last menstrual period, were obtained. All patients received a standardized anesthetic with droperidol 0.5 mg given at closure of the peritoneum. Among those patients who received droperidol added to morphine for their postoperative analgesic regimen, fewer required rescue antiemetic medication (p < 0.05, test of trend in proportions), and they had a lower incidence of vomiting (p < 0.05, test of trend in proportions), as well as a decrease in the number of times a rescue antiemetic was needed during the 24-hour postoperative period (linear trend, p = 0.013).
                An intermittent intake of low-dose droperidol with morphine given via a PCA delivery system in two treatment groups gave evidence for a dose-response relation between the amount of droperidol added and the proportion of patients needing a rescue antiemetic. The same result applied to the proportion of patients having an emetic episode and the number of times a rescue antiemetic had to be administered. There was no evidence that the low dose of droperidol added to morphine delivered via a PCA device increased unwanted side effects. Clinical observation indicates that patients undergoing transverse rectus abdominus musculocutaneous (TRAM) flap breast reconstruction surgery frequently experience postoperative nausea and/or vomiting (PONV). No controlled trials have evaluated the role of pharmacologic prophylaxis of PONV in this population. A prospective randomized, double-blinded, active-controlled trial comparing intraoperative intravenous droperidol 1 mg with dolasetron 50 mg was conducted. Seventy-one patients were included in the intention-to-treat analysis. The incidence of the primary end point of PONV within 24 hours after surgery was 81.8% versus 78.9% for droperidol and dolasetron, respectively (p = 0.8). No significant differences were detected in the time to onset of PONV, incidence of severe nausea or emesis, or incidence of emesis alone. Time to rescue antiemetic use was longer in the droperidol group (7.1 vs. 1.3 hours, p = 0.002). Adverse effects were similar between the two groups. No PONV-related complications occurred during the trial period. The incidence of PONV in TRAM flap breast reconstruction surgery patients remains high despite prophylactic intraoperative antiemetic administration. Untreated, one third of patients who undergo surgery will have postoperative nausea and vomiting. Although many trials have been conducted, the relative benefits of prophylactic antiemetic interventions given alone or in combination remain unknown.
                We enrolled 5199 patients at high risk for postoperative nausea and vomiting in a randomized, controlled trial of factorial design that was powered to evaluate interactions among as many as three antiemetic interventions. Of these patients, 4123 were randomly assigned to 1 of 64 possible combinations of six prophylactic interventions: 4 mg of ondansetron or no ondansetron; 4 mg of dexamethasone or no dexamethasone; 1.25 mg of droperidol or no droperidol; propofol or a volatile anesthetic; nitrogen or nitrous oxide; and remifentanil or fentanyl. The remaining patients were randomly assigned with respect to the first four interventions. The primary outcome was nausea and vomiting within 24 hours after surgery, which was evaluated blindly.
                Ondansetron, dexamethasone, and droperidol each reduced the risk of postoperative nausea and vomiting by about 26 percent. Propofol reduced the risk by 19 percent, and nitrogen by 12 percent; the risk reduction with both of these agents (i.e., total intravenous anesthesia) was thus similar to that observed with each of the antiemetics. All the interventions acted independently of one another and independently of the patients' baseline risk. Consequently, the relative risks associated with the combined interventions could be estimated by multiplying the relative risks associated with each intervention. Absolute risk reduction, though, was a critical function of patients' baseline risk.
                Because antiemetic interventions are similarly effective and act independently, the safest or least expensive should be used first. Prophylaxis is rarely warranted in low-risk patients, moderate-risk patients may benefit from a single intervention, and multiple interventions should be reserved for high-risk patients.
                Copyright 2004 Massachusetts Medical Society Post-operative nausea and vomiting is distressing for patients and can cause dissatisfaction and impaired well-being in the post-operative period. This study examined the question whether the reduced incidence of post-operative nausea and vomiting inevitably translates into improved clinical status and well-being. In this context high doses of droperidol were investigated. On the one hand, droperidol is known to be a powerful anti-emetic, but on the other hand there is concern about psychological effects, both in the pre- and the post-operative period. In this prospective randomized double-blinded study, droperidol (5-7.5 mg) was compared with midazolam (5-7.5 mg) used to supplement fentanyl-N2O based anaesthesia, with respect to post-operative mood and well-being using a psychological questionnaire (Bf-S-test). Furthermore, the incidence of post-operative nausea and vomiting was recorded. Out of 160 patients undergoing thyroidectomy and laparoscopic cholecystectomy, data from 150 patients were analysed. The administration of droperidol significantly lowered the incidence of post-operative nausea and vomiting from 77.8% to 55.1% compared with midazolam (P = 0.0059; chi 2-test). Although post-operative nausea and vomiting is an independent risk factor for post-operative discomfort and bad mood, patients receiving droperidol showed impaired well-being 6 h after surgery. Well-being scores returned to pre-operative base-line values and did not differ between the two groups 24 and 48 h post-operatively. The reduced incidence of post-operative nausea and vomiting achieved with high dose droperidol does not equate with increased post-operative well-being. It is an important point at issue to decide whether smaller doses of droperidol that are commonly used for anti-emetic therapy are free of these side effects. To evaluate the efficacy of a two-dose combination of droperidol and ondansetron as compared with single-dose droperidol alone, single-dose combined droperidol and ondansetron, and two-dose droperidol alone, for management of postoperative nausea and vomiting (PONV) among gynecologic laparoscopy outpatients.
                Randomized, double-blind comparison trial.
                Tertiary outpatient gynecologic unit.
                A total of 120 female patients scheduled for gynecologic laparoscopy were enrolled. Patients who had experienced nausea or vomiting, or who had taken drugs with antiemetic action in the 24-hour period prior to the study, as well as breast-feeding mothers, were excluded from participation.
                Patients were assigned to four treatment groups: i) single dose of droperidol 1.25 mg, ii) two doses of droperidol 1.25 mg, iii) single dose of droperidol 1.25 mg and ondansetron 4 mg in combination, and iv) two doses of droperidol 1.25 mg and ondansetron 4 mg in combination. The first dose of antiemetic was administered prior to induction and the second dose was given by infusion 4 hours later, prior to discharge.
                A visual analogue scale (VAS, 10 cm) was used to obtain patients' experience of nausea, vomiting, and pain at 0.5, 1.5, 2.5, and 3.5 hours after arrival at the postanesthetic care unit (PACU). Following discharge, approximately 24 hours after arrival at the PACU, the same measures were obtained by a follow-up interview using a verbal 10-point scale. No significant differences in incidence of PONV were noted among the four treatment groups (p = 0.419). However, both single- and two-dose droperidol and ondansetron combination therapy demonstrated attenuation of PONV severity in the 3.5- to 24-hour postinduction period (p < 0.05).
                The findings of this study suggest that prophylactic two-dose combined ondansetron and droperidol offers no added benefit over single-dose therapy for routine use in the gynecologic outpatient population. To compare the effectiveness of ondansetron with droperidol in preventing postoperative emesis in children after strabismus repair.
                Randomized, double-blind study.
                57 ASA physical status I and II children aged 3 to 14 years, undergoing outpatient strabismus repair in two separate study centers.
                Patients were randomized to receive either 0.15 mg/kg intravenous (i.v.) ondansetron or 0.075 mg/kg i.v. droperidol shortly after induction of anesthesia.
                Number of episodes of emesis and times to discharge from the recovery room and ambulatory center were assessed. Twenty-nine (94%) of 31 children who received ondansetron and 21 (81%) of 26 children who received droperidol were emesis-free (p = NS). There were no significant differences in the number of episodes of emesis on the day after surgery or times to discharge.
                Ondansetron is at least as effective as droperidol in reducing the frequency of emesis in children after strabismus repair, and it did not shorten times to discharge home. The low number of patients in our study may have masked a difference in effect between the two groups. The clinician should decide whether the increased cost of ondansetron justifies its use over other antiemetics. Several factors may influence the incidences of postoperative nausea and vomiting. In women, one of these factors may be the timing of their surgery in relation to their menstrual cycle. The purpose of this study was to assess the effect of menstruation and efficacy of the antiemetic droperidol on postoperative nausea and vomiting.
                In a prospective randomized double-blind clinical trial, 100 female patients who were scheduled for laparoscopic tubal sterilization were stratified on the basis of the date of their last menses into menstrual (days 1-8) and nonmenstrual (days 9-28) groups. Patients in both groups were then randomized to receive placebo or 10, 20, or 30 micrograms/kg droperidol before induction of anesthesia, and data were obtained for 24 h after completion of their surgery.
                Nausea and vomiting were reported in 55 patients, and the risk was 2.92 times greater in the menstrual group (71.4%) than in the nonmenstrual group (46.2%; (P = .013). Droperidol (30 micrograms/kg) reduced the incidence of vomiting from 47.1% (placebo) to 13.3% in the nonmenstrual group (P = .045) but had no effect in the menstrual group. Five prognostic variables (menstrual stratum, droperidol, age 30 yr or younger, weight 65 kg or less, and history of nausea and vomiting) for postoperative nausea and vomiting were tested by stepwise logistic regression. Menstrual stratum was the only variable identified as a significant (P = .017) predictor, having a percent probability equal to 2.21.
                The risk of postoperative nausea and vomiting is increased in women undergoing laparoscopic tubal sterilization during the first 8 days of their menstrual cycle, and droperidol up to 30 micrograms/kg is not as effective in these patients. The antigen capture ParaSight-F test was evaluated during a drug sensitivity survey in a hypoendemic region of northern Vietnam. When only asexual blood forms of P. falciparum were considered, sensitivity of ParaSight-F was 100%, specificity 88% (95% CI 95-80%), positive predictive value 68% (95% CI 85-50%) and negative predictive value 100%. ParaSight-F proved very convenient for rapid screening and selection of patients to enrol in a drug sensitivity study. In northern Vietnam, the introduction of the test as a routine diagnostic tool is not justified, considering its high cost, the necessity to carry out the treatment of presumptive Plasmodium vivax cases and the persistence of positive reactions following treatment. However, the test will be a valuable tool in remote areas in emergency situations, where rapid confirmation of a P. falciparum outbreak is required. We compare intravenous midazolam and droperidol for the onset of sedation of acutely agitated patients in the emergency department (ED).
                This was a double-blind, randomized, clinical trial set in the ED of a university teaching hospital. Subjects were adults, acutely agitated because of mental illness, intoxication, or both, who received midazolam or droperidol, 5 mg intravenously, every 5 minutes until sedated. We analyzed time to sedation using survival analysis, median times to sedation, and proportions sedated at 5 and 10 minutes.
                Seventy-four patients received midazolam; 79 patients, droperidol. Survival analysis showed no difference in time to sedation (hazard ratio 0.86; 95% confidence interval [CI] 0.61 to 1.23), P=.42. Median time to sedation was 6.5 minutes for midazolam (median dose 5 mg) and 8 minutes for droperidol (median dose 10 mg), P=.075 (effect size 1.5 minutes; 95% CI 0 to 4 minutes). At 5 minutes, 33 of 74 (44.6%) patients from the midazolam group were adequately sedated compared with 13 of 79 (16.5%) patients from the droperidol group, a difference of 28.1% (95% CI 12.9% to 43.4%; P<.001). By 10 minutes, 41 of 74 (55.4%) from the midazolam group were sedated compared to 42 of 79 (53.2%) from droperidol, a difference of 2.2% (95% CI -14.9% to 19.3%; P=.91). Eleven adverse events occurred in the midazolam group and 10 in the droperidol group. Three patients required active airway management (3 patients with assisted ventilation and 1 patient intubated); all received midazolam.
                There is no difference in onset of adequate sedation of agitated patients using midazolam or droperidol. Patients sedated with midazolam may have an increased need for active airway management. Women undergoing laparoscopic surgery are susceptible to postoperative nausea and vomiting (PONV). Ondansetron and droperidol are useful antiemetics. This study was designed to ascertain primarily the relative difference in efficacy of ondansetron and droperidol and secondarily between these drugs and placebo in the prevention of PONV after laparoscopic surgery.
                The prophylactic antiemetic efficacy of ondansetron and droperidol was compared in a prospective, randomised, double-blind, placebo-controlled trial of 439 female inpatients scheduled for laparoscopic surgery. During induction of standardised general anaesthesia the patients received intravenously either ondansetron 8 mg (n=195), droperidol 1.25 mg (n=193) or placebo (n=51). The occurrence of nausea, vomiting, side-effects and the need for rescue antiemetic medication were recorded for 24 h postoperatively.
                The proportion of patients with nausea was 48%, 50% and 67% in the ondansetron, droperidol and placebo groups, respectively; with a significant difference when both ondansetron (P=0.02) and droperidol (P=0.04) were compared with placebo. Vomiting occurred in 18%, 26% and 37% of the patients in the three groups, respectively (P=0.05 between ondansetron and droperidol, P=0.004 between ondansetron and placebo, P=0.16 between droperidol and placebo). The proportion of patients given rescue medication was 34%, 28% and 49%, respectively (P=0.23 for ondansetron and droperidol, P=0.07 for ondansetron and placebo, P=0.007 for droperidol and placebo). During early recovery the patients treated with ondansetron were significantly more alert than after droperidol. Serious side-effects were not observed. Headache was significantly more common after ondansetron than after droperidol treatment.
                The efficacy of prophylactic ondansetron and droperidol in reducing postoperative nausea associated with laparoscopic surgery in female inpatients was similar, but ondansetron appeared to be slightly more efficient than droperidol in preventing vomiting. Ondansetron and droperidol were both significantly better than placebo in the prophylaxis of PONV. In 87 children aged 2-9 yr, oral droperidol and oral droperidol plus diazepam were compared as premedicants in a controlled double-blind clinical trial. Atropine was given orally to all the patients. Droperidol was well absorbed and produced good sedation, associated with a low incidence of vomiting after operation. Droperidol plus diazepam did not appear to offer any advantage over droperidol alone. Anxiety and extrapyramidal effects were not observed and may have been obviated by the addition of atropine. Droperidol syrup was noted to be more palatable than other oral premedicants in use.
This is an important, and surprisingly under-researched, area. To date, use of droperidol for emergency situations has been justified by experience rather than evidence from well conducted and reported randomised trials, but, as world reserves diminish, droperidol will no longer be a treatment option.