1. International, multicentre, placebo-controlled study to evaluate the effectiveness of ondansetron vs. metoclopramide in the prevention of post-operative nausea and vomiting
- Author
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M. Rust, L. Hasselstrøm, H. Aune, J. R. Maltby, D. A. Rocke, R. W. Morris, P. Feiss, A. Hanson, L. A. Cohen, and B. Rozenberg
- Subjects
Adult ,Adolescent ,Metoclopramide ,Vomiting ,Nausea ,medicine.drug_class ,medicine.medical_treatment ,Placebo-controlled study ,Anesthesia, General ,Placebo ,Ondansetron ,Gynecologic Surgical Procedures ,Postoperative Complications ,Double-Blind Method ,medicine ,Humans ,Antiemetic ,Chemotherapy ,business.industry ,Middle Aged ,Anesthesiology and Pain Medicine ,Anesthesia ,Antiemetics ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
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.
- Published
- 1998
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