SummaryIn two placebo-controlled, double-blind, multicentre 0.007; nausea p Key wordsPharmacology; ondansetron, oral formulation. Complications; nausea and vomiting. Receptors; 5-HT3. Vomiting; antiemetics, prophylaxis.Postoperative nausea and vomiting (PONV) are among the most common complications that occur after surgery performed under general anaesthesia, with female patients being particularly susceptible [ 11. Other factors, including a previous history of PONV and the site of surgery, are thought to influence the occurrence of these problems [2].In two earlier studies, a three-dose oral regimen of ondansetron 8 mg has been shown to be effective and well tolerated in preventing PONV [3,4]. A single dose of intravenous ondansetron 4 mg has also been shown to be effective and well tolerated in preventing and treating established PONV [5,6]. Two further studies were undertaken to examine whether a single oral dose of ondansetron would be effective in preventing PONV both in patients with and without a previous history of PONV undergoing gynaecological and non-gynaecological surgery. The studies also aimed to identify the optimum dose of ondansetron in terms of efficacy and safety. MethodBoth studies were double-blind, placebo-controlled, and multicentre, with one being performed in 34 centres across nine European countries
In a placebo-controlled, double-blind study, we have compared the efficacy of ondansetron 16 mg, 8 mg and 1 mg administered 8-hourly for prevention of postoperative nausea and vomiting. We studied 995 patients undergoing major gynaecological surgery; 982 were included in the analysis. Study medication was administered 1 h before induction of anaesthesia and second and third doses were given 8 and 16 h after the first. The treatment groups were similar for patient characteristics, surgical procedures, anaesthetics administered and opioids given. The frequency of nausea was 75%, 70%, 56% and 55% after placebo and ondansetron 1 mg, 8 mg and 16 mg, respectively; the corresponding frequencies of vomiting were 60%, 55%, 37% and 37%. Ondansetron 8 mg was as effective as 16 mg and both resulted in significant reductions in nausea and vomiting compared with placebo and ondansetron 1 mg (P less than 0.001).
Ondansetron 4 mg was compared with metoclopramide 10 mg for prevention of post-operative nausea and emesis in in-patients undergoing major gynaecological surgery in this double-blind, randomized, placebo-controlled, multicentre study. A total of 1044 patients received a single intravenous (i.v.) injection of study medication immediately before induction of anaesthesia. Nausea and emesis were assessed over the 24 h post-operative period. Significantly more patients who received ondansetron experienced no emetic episodes (44%) compared with those who received metoclopramide (37%, P = 0.049) or placebo (25%, P < 0.001). No nausea was experienced by significantly more patients who received ondansetron (32%) than with patients who received metoclopramide (24%, P = 0.009) or placebo (16%, P < 0.001). In addition, fewer emetic episodes, less severe nausea and a reduced need for rescue antiemetics were also observed with ondansetron (P < 0.05 vs. metoclopramide and placebo). Metoclopramide and placebo-treated patients were also 1.5 times (95% Cl 1.5-4.2) and 2.5 times (95% Cl 1.1-2.0) more likely, respectively, to experience nausea post-operatively. Overall, ondansetron was the most effective antiemetic in this patient population.
tron (32%) than with patients who received metoclopramide (24%, P=0.009) or placebo (16%, P<0.001). Ondansetron 4 mg was compared with me-In addition, fewer emetic episodes, less severe nausea toclopramide 10 mg for prevention of post-operative and a reduced need for rescue antiemetics were also nausea and emesis in in-patients undergoing major observed with ondansetron (P<0.05 vs. megynaecological surgery in this double-blind, rantoclopramide and placebo). Metoclopramide and domized, placebo-controlled, multicentre study. A placebo-treated patients were also 1.5 times (95% CI total of 1044 patients received a single intravenous 1.5-4.2) and 2.5 times (95% CI 1.1-2.0) more likely, (i.v.) injection of study medication immediately before respectively, to experience nausea post-operatively. induction of anaesthesia. Nausea and emesis were Overall, ondansetron was the most effective antiassessed over the 24 h post-operative period. Sigemetic in this patient population. nificantly more patients who received ondansetron experienced no emetic episodes (44%) compared with
This randomized, double-blind, multicentre, parallel-group study compared the efficacy and safety of an intravenous dose of ondansetron 4 mg for the prevention of postoperative nausea and vomiting (PONV) with metoclopramide 10 mg and placebo in patients undergoing major gynaecological surgery. A total of 1044 patients (465 ondansetron, 462 metoclopramide, 117 placebo) received study medication immediately prior to induction of anaesthesia and were included in the analysis of data. The proportion of patients experiencing no emesis and no nausea or provided with rescue antiemetic medication, the number of emetic episodes, and the duration and severity of nausea were recorded during the 24-h period after recovery. Significantly more patients who received ondansetron had no emetic episodes (44%) than those who received metoclopramide (36%, P = 0.049) or placebo (25%, P < 0.001). A higher proportion of patients receiving ondansetron (32%) did not experience nausea (metoclopramide 24%, P = 0.009; placebo 16%, P < 0.001). Significantly fewer patients in the ondansetron group required rescue medication or were withdrawn due to treatment failure (P < 0.05). In the ondansetron group the total number of emetic episodes, the median time to the first emetic episode or treatment failure, and the duration and severity of nausea were reduced significantly compared with metoclopramide or placebo (P < 0.05). The safety profile was similar for each treatment group.
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