Ondansetron in the treatment of postoperative nausea and vomiting in ambulatory outpatients: a dose-comparative, stratified, multicentre study.
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 (1 mg), 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.
Du Pen
S
S
Department of Anaesthesiology, Swedish Hospital Medical Center, Seattle, Washington 98104.
Scuderi
P
P
Wetchler
B
B
Sung
Y F
YF
Mingus
M
M
Clayborn
L
L
Leslie
J
J
Talke
P
P
Apfelbaum
J
J
Sharifi-Azad
S
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D000556:Ambulatory Surgical Procedures; D002648:Child; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000188:drug therapy*; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011183:Postoperative Complications / Q000188:drug therapy*; D012074:Remission Induction; D012449:Safety; D013997:Time Factors; D014839:Vomiting / Q000188:drug therapy*
D010919:Placebos; D017294:Ondansetron