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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