Ondansetron in the treatment of postoperative nausea and vomiting in ambulatory outpatients: A dose-comparative, stratified, multicentre study

S. Du Pen, P. Scuderi, B. Wetchler, Y. F. Sung, M. Mingus, L. Clayborn, J. Leslie, P. Talke, J. Apfelbaum, S. Sharifi-Azad, M. Williams

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44 Scopus citations

Abstract

The safety and efficacy of ondansetron were evaluated in the treatment of postoperative nausea and vomiting. Five hundred patients who experienced nausea or vomiting in the Post-Anaesthesia Care Unit within the first 2 h of recovery were randomized to receive either 1, 4, or 8 mg of ondansetron, or placebo. All patients had undergone ambulatory surgery with general endotracheal anaesthesia. Episodes of emesis, nausea scores, adverse events, vital signs, and laboratory values were assessed before and during the 24 h after study drug administration. Patients were evaluated for the first 2 h in the Post-Anaesthesia Care Unit then followed up for the next 22 h. Complete response was defined as no emetic episodes, no nausea or no rescue anti-emetic medication. For the 0-24 h study period, complete response occurred in only 15% of the placebo group compared to 41%, 47%, and 47% in the 1, 4, and 8 mg ondansetron groups, respectively. Mean nausea scores (scale of 0-10) during the initial observation period (0-2 h) were significantly lower for all doses of ondansetron [2.2 (1mg), 1.7 (4 mg), and 2.1(8 mg)] compared to placebo (3.0). The optimal dose of ondansetron for the treatment of postoperative nausea and vomiting was found to be 4 mg. All doses of ondansetron were well tolerated. No clinically significant increases in laboratory parameters or alterations in haemodynamic stability occurred in the ondansetron groups compared to placebo.

Original languageEnglish (US)
Pages (from-to)55-62
Number of pages8
JournalEuropean Journal of Anaesthesiology, Supplement
Volume9
Issue number6
StatePublished - Jan 1 1992

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

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    Du Pen, S., Scuderi, P., Wetchler, B., Sung, Y. F., Mingus, M., Clayborn, L., Leslie, J., Talke, P., Apfelbaum, J., Sharifi-Azad, S., & Williams, M. (1992). Ondansetron in the treatment of postoperative nausea and vomiting in ambulatory outpatients: A dose-comparative, stratified, multicentre study. European Journal of Anaesthesiology, Supplement, 9(6), 55-62.