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The British Journal of Theatre Nursing... Dec 1999To determine the efficacy and safety of ondansetron for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults. (Review)
Review
OBJECTIVES
To determine the efficacy and safety of ondansetron for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults.
DESIGN
Systematic review of published double-blind randomised controlled trials.
DATA SOURCES
Twenty seven trials from 1990 to July 1998 retrieved from a systematic literature search (Medline, Cinahl, Embase, Cochrane Library, reference lists, hand searching of anaesthetic journals, & provided manufacturer information); restricted to English language.
MAIN OUTCOME MEASURES
Estimation of efficacy (incidence of complete absence of nausea or other outcome measure as defined by the authors) at 24 hours.
RESULTS
Seven double-blind randomised controlled trials with 1,623 patients studied intravenous ondansetron 1 mg, 4 mg, or 8 mg for the treatment of postoperative nausea and vomiting (PONV). Four mg, compared with metoclopramide 10 mg, produced higher patient satisfaction scores and an increased incidence of freedom from nausea at 24 hours. Further studies are required to compare the safety, efficacy and dose response with other anti-emetics at 24 hours. Twenty double-blind randomised controlled trials with 4,364 patients studied intravenous and oral administration of ondansetron 1 mg, 4 mg, and 8 mg for the prevention of postoperative nausea and vomiting. There appears to be no significant difference between droperidol (0.625 mg, 1 mg or 1.25 mg) i.v. and ondansetron 4 mg in efficacy and incidence of side effects. Compared with metoclopramide, ondansetron produced less nausea but the incidence of vomiting was the same at 24 hours.
CONCLUSIONS
Further PONV could be prevented with ondansetron 4 mg compared with placebo and metoclopramide 10 mg. Further studies are required to compare ondansetron with other anti-emetics for the treatment of PONV. For prophylaxis of PONV ondansetron 4 mg appears to be equal to low dose droperidol in efficacy and the incidence of side effects, and superior to metoclopramide. Ondansetron should perhaps be limited to second line treatment in view of patient satisfaction, efficacy and cost when compared with droperidol.
Topics: Adult; Antiemetics; Double-Blind Method; Humans; Ondansetron; Patient Satisfaction; Postoperative Care; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
PubMed: 10887851
DOI: 10.1177/175045899900901201 -
Anesthesia and Analgesia Jan 2000The role of dexamethasone in the prevention of postoperative nausea and vomiting (PONV) is unclear. We reviewed efficacy and safety data of dexamethasone for prevention... (Meta-Analysis)
Meta-Analysis
UNLABELLED
The role of dexamethasone in the prevention of postoperative nausea and vomiting (PONV) is unclear. We reviewed efficacy and safety data of dexamethasone for prevention of PONV. A systematic search (MEDLINE, EMBASE, Cochrane Library, hand searching, bibliographies, all languages, up to April 1999) was done for full reports of randomized comparisons of dexamethasone with other antiemetics or placebo in surgical patients. Relevant end points were prevention of early PONV (0 to 6 h postoperatively), late PONV (0 to 24 h), and adverse effects. Data from 1,946 patients from 17 trials were analyzed: 598 received dexamethasone; 582 received ondansetron, granisetron, droperidol, metoclopramide, or perphenazine; 423 received a placebo; and 343 received a combination of dexamethasone with ondansetron or granisetron. With placebo, the incidence of early and late PONV was 35% and 50%, respectively. Sixteen different regimens of dexamethasone were tested, most frequently, 8 or 10 mg IV in adults, and 1 or 1.5 mg/kg IV in children. With these doses, the number needed to treat to prevent early and late vomiting compared with placebo in adults and children was 7.1 (95% CI 4.5 to 18), and 3.8 (2.9 to 5), respectively. In adults, the number needed to treat to prevent late nausea was 4.3 (2.3 to 26). The combination of dexamethasone with ondansetron or granisetron further decreased the risk of PONV; the number needed to treat to prevent late nausea and vomiting with the combined regimen compared with the 5-HT3 receptor antagonists alone was 7.7 (4.8 to 19) and 7.8 (4.1 to 66), respectively. There was a lack of data from comparisons with other antiemetics for sensible conclusions. There were no reports on dexamethasone-related adverse effects.
IMPLICATIONS
When there is a high risk of postoperative nausea and vomiting, a single prophylactic dose of dexamethasone is antiemetic compared with placebo, without evidence of any clinically relevant toxicity in otherwise healthy patients. Late efficacy seems to be most pronounced. It is very likely that the best prophylaxis of postoperative nausea and vomiting currently available is achieved by combining dexamethasone with a 5-HT3 receptor antagonist. Optimal doses of this combination need to be identified.
Topics: Adult; Antiemetics; Dexamethasone; Drug Therapy, Combination; Humans; Postoperative Nausea and Vomiting; Serotonin Antagonists
PubMed: 10625002
DOI: 10.1097/00000539-200001000-00038 -
Anesthesia and Analgesia Jun 1999Postoperative nausea and vomiting are important causes of morbidity after anesthesia and surgery. We performed a meta-analysis of published, randomized, controlled... (Meta-Analysis)
Meta-Analysis
UNLABELLED
Postoperative nausea and vomiting are important causes of morbidity after anesthesia and surgery. We performed a meta-analysis of published, randomized, controlled trials to determine the relative efficacy and safety of ondansetron, droperidol, and metoclopramide for the prevention of postoperative nausea and vomiting. We performed a literature search of English references using both the MEDLINE database and a manual search. Double-blinded, randomized, controlled trials comparing the efficiency of the prophylactic administration of ondansetron, droperidol, and/or metoclopramide therapy during general anesthesia were included. A total of 58 studies were identified, of which 4 were excluded for methodological concerns. For each comparison of drugs, a pooled odds ratio (OR) with a 95% CI was calculated using a random effects model. Ondansetron (pooled OR 0.43, 95% CI 0.31, 0.61; P < 0.001) and droperidol (pooled OR 0.68, 95% CI 0.54, 0.85; P < 0.001) were more effective than metoclopramide in preventing vomiting. Ondansetron was more effective than droperidol in preventing vomiting in children (pooled OR 0.49; P = 0.004), but they were equally effective in adults (pooled OR 0.87; P = 0.45). The overall risk of adverse effects was not different among drug combinations. We conclude that ondansetron and droperidol are more effective than metoclopramide in reducing postoperative vomiting.
IMPLICATIONS
We performed a systematic review of published, randomized, controlled trials to determine the relative efficacy and safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting. Ondansetron and droperidol were more effective than metoclopramide in reducing postoperative vomiting. The overall risk of adverse effects did not differ.
Topics: Adult; Antiemetics; Child; Droperidol; Female; Humans; Male; Metoclopramide; Ondansetron; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic
PubMed: 10357347
DOI: 10.1097/00000539-199906000-00032 -
Anesthesia and Analgesia Jun 1999Nausea and vomiting are frequent adverse effects of patient-controlled analgesia (PCA) with opioids. To identify the optimal prophylactic antiemetic intervention in this... (Meta-Analysis)
Meta-Analysis
UNLABELLED
Nausea and vomiting are frequent adverse effects of patient-controlled analgesia (PCA) with opioids. To identify the optimal prophylactic antiemetic intervention in this setting, we performed a systematic search for randomized trials (MEDLINE, EMBASE, Cochrane library, reference lists, hand-searching, no language restriction) published up to May 1998 that compared prophylactic antiemetic interventions with placebo or no treatment in the postoperative PCA-setting with opioids. Fourteen placebo-controlled trials (1117 patients) with different regimens of droperidol, ondansetron, hyoscine TTS, tropisetron, metoclopramide, propofol, and promethazine were analyzed. One PCA was with tramadol, all others were with morphine. At 24 h, the cumulative incidence of nausea and vomiting without antiemetics was approximately 50%. Droperidol 0.017-0.17 mg/mg of morphine (0.5-11 mg/d droperidol) was statistically significantly more effective than placebo without evidence of dose-responsiveness; the number needed to treat to prevent nausea compared with placebo was 2.7 (95% confidence interval 1.8-5.2), and that to prevent vomiting was 3.1 (2.3-4.8). Compared with placebo, the incidence of minor adverse effects with droperidol was increased with doses >4 mg/d.
IMPLICATIONS
Of 100 patients treated with droperidol added in a patient-controlled analgesia pump with morphine, 30 who would have vomited or been nauseated had they not received droperidol will not suffer these effects. There is no evidence of dose-responsiveness for efficacy with droperidol, but the risk of adverse effects is dose-dependent. There is a lack of evidence for other antiemetics.
Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Antiemetics; Droperidol; Humans; Morphine; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic; Risk Assessment
PubMed: 10357345
DOI: 10.1097/00000539-199906000-00030 -
BMJ (Clinical Research Ed.) Apr 1997To test the evidence for a dose-response with ondansetron for treatment of postoperative nausea and vomiting and to establish whether differences in efficacy between... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To test the evidence for a dose-response with ondansetron for treatment of postoperative nausea and vomiting and to establish whether differences in efficacy between doses are of clinical relevance.
DESIGN
Quantitative systematic review of published randomised controlled trials.
DATA SOURCES
Seven trials from 1991 to January 1996 retrieved from a systematic literature search (Medline, reference lists, hand searching of anaesthetic journals, manufacturer's database); no restriction on language.
MAIN OUTCOME MEASURES
Estimation of efficacy (incidence of complete control of further nausea and vomiting) by using odds ratios and the "number needed to treat" method for early (within 6 hours of administration) and late (within 24 hours) periods.
RESULTS
Four placebo controlled trials with 1043 patients studied intravenous ondansetron 1 mg, 4 mg, or 8 mg. All doses were more efficacious than placebo in preventing further episodes of nausea or vomiting. For combined data, the point estimates for the number needed to treat were between 3.1 (8 mg) and 3.8 (1 mg) for early efficacy and between 4.1 (8 mg) and 4.8 (1 mg) for late efficacy, without significant differences between doses. No difference was found between ondansetron and droperidol in two trials with 129 patients or between ondansetron and metoclopramide in one trial with 80 patients.
CONCLUSIONS
Further nausea and vomiting could be prevented with ondansetron compared with placebo in 25% of patients who had nausea or vomiting (number needed to treat, about 4). There was no evidence of a clinically relevant dose-response between 1 mg and 8 mg or a difference between ondansetron and either droperidol or metoclopramide in a limited dataset. A false impression of ondansetron's efficacy may arise because a quarter of all relevant published reports are duplicates, and reporting of study results is uncritical.
Topics: Antiemetics; Dose-Response Relationship, Drug; Humans; Nausea; Ondansetron; Postoperative Complications; Randomized Controlled Trials as Topic; Treatment Outcome; Vomiting
PubMed: 9133892
DOI: 10.1136/bmj.314.7087.1088 -
British Journal of Anaesthesia Nov 1995Randomized controlled studies were reviewed to assess the effectiveness and safety of antiemetics used for prophylaxis in paediatric strabismus surgery. Early and late... (Review)
Review
Randomized controlled studies were reviewed to assess the effectiveness and safety of antiemetics used for prophylaxis in paediatric strabismus surgery. Early and late vomiting (6 and 48 h after operation, respectively), and adverse effects were evaluated using the numbers-needed-to-treat method. In 27 reports with information on 2033 children, the mean incidence of early vomiting was 54% and of late vomiting 59%, without prophylaxis. Only three drugs were studied sufficiently for firm conclusions to be drawn. In the best documented regimen (droperidol 75 micrograms kg-1), four children have to be given the drug to prevent one vomiting; of the three others, one may vomit and two would not have vomited anyway; fewer than one child in 100 may have an extrapyramidal reaction and 16 may have minor adverse effects. Metoclopramide 0.15 and 0.25 mg kg-1 was significantly better than control only for early vomiting. Propofol had a high incidence of oculocardiac reflex without conferring any significant antiemetic effect: it should not be used. The benefits of prophylactic antiemetic therapy are not proven.
Topics: Antiemetics; Child; Droperidol; Humans; Postoperative Complications; Propofol; Randomized Controlled Trials as Topic; Strabismus; Vomiting
PubMed: 7577280
DOI: 10.1093/bja/75.5.556