BACKGROUND: Neither droperidol nor ondansetron has been proven completely effective, and there are conflicting data comparing the efficacy of the two agents. The purpose of this study was to compare the efficacy, safety and cost of a combination of ondansetron administered intravenously in the operating room followed by oral ondansetron treatment at home with the more commonly used treatment of intravenous droperidol therapy and oral dimenhydrinate therapy, for the prevention and treatment of postoperative nausea and vomiting in children undergoing strabismus surgery. METHODS: Double-blind randomized clinical trial with parallel comparison groups. All patients aged 6 months to 18 years who underwent strabismus surgery at a pediatric hospital in Montreal between Nov. 13, 2000, and June 12, 2001, were included. The exclusion criteria were nausea or vomiting, or use of antiemetics or narcoticsin the 24 hours preceding surgery, and past history of hepatic, gastric or renal disease. The outcome measures were frequency of nausea and vomiting, severity of nausea and adverse effects in hospital, during transportation home and during the first 24 hours at home. Data were obtained through nursing notes and through a telephone interview conducted 24 to 48 hours after discharge. RESULTS: Of the 208 eligible patients, 172 were randomly assigned to the study groups (88 to theondansetron group and 84 to the droperidol/dimenhydrinate group). We found no statistically significant difference in the incidence of nausea and vomiting in hospital or at home between the two groups (25.3% vs. 31.6%, p = 0.371). There was a significant difference between the two groups in the rate of vomiting during transportation home (3.6% vs. 12.6%, p = 0.044). The incidence of severe nausea was 14.4% with ondansetron and 15.4% with droperidol, a nonsignificant difference (p = 1.00). No significant difference was observed between the two groups in the incidence of any nausea (p = 0.434) or adverse effects (p = 0.220). We calculated that the combination of droperidol and dimenhydrinate was seven times less costly than the ondansetron regimen. INTERPRETATION: In this study, the efficacy and safety of intravenous administration of droperidol followed by oral use of dimenhydrinate did not differ from that of intravenous followed by oral use of ondansetron in children undergoing strabismus surgery. Since treatment with ondansetron is much more costly than the combination of droperidol and dimenhydrinate, at this time the use of ondansetron in the prevention and treatment of vomiting and nausea in this population may not be beneficial on a cost basis if all other variables are considered.
RCT Entities:
BACKGROUND: Neither droperidol nor ondansetron has been proven completely effective, and there are conflicting data comparing the efficacy of the two agents. The purpose of this study was to compare the efficacy, safety and cost of a combination of ondansetron administered intravenously in the operating room followed by oral ondansetron treatment at home with the more commonly used treatment of intravenous droperidol therapy and oral dimenhydrinate therapy, for the prevention and treatment of postoperative nausea and vomiting in children undergoing strabismus surgery. METHODS: Double-blind randomized clinical trial with parallel comparison groups. All patients aged 6 months to 18 years who underwent strabismus surgery at a pediatric hospital in Montreal between Nov. 13, 2000, and June 12, 2001, were included. The exclusion criteria were nausea or vomiting, or use of antiemetics or narcotics in the 24 hours preceding surgery, and past history of hepatic, gastric or renal disease. The outcome measures were frequency of nausea and vomiting, severity of nausea and adverse effects in hospital, during transportation home and during the first 24 hours at home. Data were obtained through nursing notes and through a telephone interview conducted 24 to 48 hours after discharge. RESULTS: Of the 208 eligible patients, 172 were randomly assigned to the study groups (88 to the ondansetron group and 84 to the droperidol/dimenhydrinate group). We found no statistically significant difference in the incidence of nausea and vomiting in hospital or at home between the two groups (25.3% vs. 31.6%, p = 0.371). There was a significant difference between the two groups in the rate of vomiting during transportation home (3.6% vs. 12.6%, p = 0.044). The incidence of severe nausea was 14.4% with ondansetron and 15.4% with droperidol, a nonsignificant difference (p = 1.00). No significant difference was observed between the two groups in the incidence of any nausea (p = 0.434) or adverse effects (p = 0.220). We calculated that the combination of droperidol and dimenhydrinate was seven times less costly than the ondansetron regimen. INTERPRETATION: In this study, the efficacy and safety of intravenous administration of droperidol followed by oral use of dimenhydrinate did not differ from that of intravenous followed by oral use of ondansetron in children undergoing strabismus surgery. Since treatment with ondansetron is much more costly than the combination of droperidol and dimenhydrinate, at this time the use of ondansetron in the prevention and treatment of vomiting and nausea in this population may not be beneficial on a cost basis if all other variables are considered.
Authors: John T Mondick; Brendan M Johnson; Lynda J Haberer; Mark E Sale; Peter C Adamson; Charles J Coté; James M Croop; Mark W Russo; Jeffrey S Barrett; J Frank Hoke Journal: Eur J Clin Pharmacol Date: 2009-10-02 Impact factor: 2.953