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RETRACTED ARTICLE

A comparison of granisetron, droperidol, and metoclopramide in the treatment of established nausea and vomiting after breast surgery: a double-blind, randomized, controlled trial.
Clin Ther. 2003 Apr; 25(4):1142-9.CT

Abstract

BACKGROUND

Women 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.

OBJECTIVE

This 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.

METHODS

In 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.

RESULTS

Seventy-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.

CONCLUSION

Granisetron was significantly more effective than the traditional antiemetics droperidol and metoclopramide for the treatment of PONV in this population of patients undergoing breast surgery.

Authors+Show Affiliations

Department of Anesthesiology, Toride Kyodo General Hospital, Toride City, Ibaraki, Japan. yfujii@md.tsukuba.ac.jpNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Retracted Publication

Language

eng

PubMed ID

12809962

Citation

Fujii, Yoshitaka, et al. "A Comparison of Granisetron, Droperidol, and Metoclopramide in the Treatment of Established Nausea and Vomiting After Breast Surgery: a Double-blind, Randomized, Controlled Trial." Clinical Therapeutics, vol. 25, no. 4, 2003, pp. 1142-9.
Fujii Y, Tanaka H, Kawasaki T. A comparison of granisetron, droperidol, and metoclopramide in the treatment of established nausea and vomiting after breast surgery: a double-blind, randomized, controlled trial. Clin Ther. 2003;25(4):1142-9.
Fujii, Y., Tanaka, H., & Kawasaki, T. (2003). A comparison of granisetron, droperidol, and metoclopramide in the treatment of established nausea and vomiting after breast surgery: a double-blind, randomized, controlled trial. Clinical Therapeutics, 25(4), 1142-9.
Fujii Y, Tanaka H, Kawasaki T. A Comparison of Granisetron, Droperidol, and Metoclopramide in the Treatment of Established Nausea and Vomiting After Breast Surgery: a Double-blind, Randomized, Controlled Trial. Clin Ther. 2003;25(4):1142-9. PubMed PMID: 12809962.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparison of granisetron, droperidol, and metoclopramide in the treatment of established nausea and vomiting after breast surgery: a double-blind, randomized, controlled trial. AU - Fujii,Yoshitaka, AU - Tanaka,Hiroyoshi, AU - Kawasaki,Tsuneo, PY - 2003/6/18/pubmed PY - 2003/8/30/medline PY - 2003/6/18/entrez SP - 1142 EP - 9 JF - Clinical therapeutics JO - Clin Ther VL - 25 IS - 4 N2 - BACKGROUND: Women 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. OBJECTIVE: This 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. METHODS: In 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. RESULTS: Seventy-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. CONCLUSION: Granisetron was significantly more effective than the traditional antiemetics droperidol and metoclopramide for the treatment of PONV in this population of patients undergoing breast surgery. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/12809962/A_comparison_of_granisetron_droperidol_and_metoclopramide_in_the_treatment_of_established_nausea_and_vomiting_after_breast_surgery:_a_double_blind_randomized_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149291803800723 DB - PRIME DP - Unbound Medicine ER -