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Clinical therapeutics · Apr 2003
Randomized Controlled Trial Comparative Study Clinical TrialA comparison of granisetron, droperidol, and metoclopramide in the treatment of established nausea and vomiting after breast surgery: a double-blind, randomized, controlled trial.
- Yoshitaka Fujii, Hiroyoshi Tanaka, and Tsuneo Kawasaki.
- Department of Anesthesiology, Toride Kyodo General Hospital, Toride City, Ibaraki, Japan. yfujii@md.tsukuba.ac.jp
- Clin Ther. 2003 Apr 1;25(4):1142-9.
BackgroundWomen undergoing breast surgery are at particular risk for post-operative nausea and vomiting (PONV), with an incidence of emesis as high as 50% when no prophylactic antiemetic is used.ObjectiveThis study compared the efficacy of the selective 5-hydroxytryptamine(3) receptor antagonist granisetron with that of the traditional antiemetics droperidol and metoclopramide in the treatment of established PONV after breast surgery.MethodsIn this prospective, randomized, double-blind trial, patients who had undergone breast surgery and were experiencing PONV during the first 3 hours after anesthesia received either granisetron 40 microg/kg IV, droperidol 20 microg/kg IV, or metoclopramide 0.2 mg/kg IV. Patients were observed for 24 hours after administration of study drug. Emetic episodes were recorded by nursing staff who were blinded to treatment assignment.ResultsSeventy-five patients were enrolled in the study, 25 in each treatment group. Their age ranged from 41 to 65 years. There were no significant between-group differences in patients' demographic or surgical characteristics at study entry. The number of patients who were emesis free (no nausea, retching, or vomiting) was significantly higher in patients who received granisetron (88% [2225]) than in those who received droperidol (64% [1625]; P = 0.047) or metoclopramide (56% [1425]; P = 0.013). In patients who experienced nausea (3, 8, and 9 patients in the granisetron, droperidol, and metoclopramide groups, respectively), the severity of nausea was significantly lower with granisetron compared with droperidol (P = 0.028) and metoclopramide (P = 0.025). No clinically serious adverse events were observed in any group.ConclusionGranisetron was significantly more effective than the traditional antiemetics droperidol and metoclopramide for the treatment of PONV in this population of patients undergoing breast surgery.
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