INTERNATIONAL, MULTICENTER, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECTIVENESS OF ONDANSETRON VS. METOCLOPRAMIDE IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING

Ondansetron 4 mg was compared with metoclopramide 10 mg for prevention of post-operative nausea and emesis in in-patients undergoing major g ynaecological surgery in this double-blind, randomized, placebo-contro lled, multicentre study. A total of 1044 patients received a single in travenous (i.v.) injection of study medication immediately before indu ction of anaesthesia. Nausea and emesis were assessed over the 24 h po st-operative period. Significantly more patients who received ondanset ron experienced no emetic episodes (44%) compared with those who recei ved metoclopramide (37%, P=0.049) or placebo (25%, P<0.001). No nausea was experienced by significantly more patients who received ondansetr on (32%) than with patients who received metoclopramide (24%, P=0.009) or placebo (16%, P<0.001). In addition, fewer emetic episodes, less s evere nausea and a reduced need for rescue antiemetics were also obser ved with ondansetron (P<0.05 vs. metoclopramide and placebo). Metoclop ramide and placebo-treated patients were also 1.5 times (95% CI 1.5-4. 2) and 2.5 times (95% CI 1.1-2.0) more likely, respectively, to experi ence nausea post-operatively. Overall, ondansetron was the most effect ive antiemetic in this patient population.