Caron Elaine, Bussières Jean-François, Lebel Denis, Mathews Sylvain, Milot Jean, Jacob Jean-Louis, Moride Yola, Lortie Louise
Department of Pharmacy, Hôpital Sainte-Justine, Montreal, Que.
Can J Ophthalmol. 2003 Apr;38(3):214-22. doi: 10.1016/s0008-4182(03)80063-7.
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.
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.
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.
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.
氟哌利多和昂丹司琼均未被证实完全有效，且比较这两种药物疗效的数据相互矛盾。本研究的目的是比较手术室静脉注射昂丹司琼后在家口服昂丹司琼治疗与更常用的静脉注射氟哌利多治疗和口服茶苯海明治疗在预防和治疗斜视手术患儿术后恶心呕吐方面的疗效、安全性和成本。
采用平行比较组的双盲随机临床试验。纳入2000年11月13日至2001年6月12日在蒙特利尔一家儿科医院接受斜视手术的所有6个月至18岁患者。排除标准为术前24小时内有恶心或呕吐、使用过止吐药或麻醉药，以及有肝、胃或肾疾病史。观察指标为恶心呕吐频率、住院期间、回家途中及回家后首24小时内恶心的严重程度和不良反应。数据通过护理记录以及出院后24至48小时进行的电话访谈获得。
208名符合条件的患者中，172名被随机分配至研究组（88名至昂丹司琼组，84名至氟哌利多/茶苯海明组）。我们发现两组在医院或家中恶心呕吐的发生率无统计学显著差异（25.3%对31.6%，p = 0.371）。两组在回家途中呕吐发生率上存在显著差异（3.6%对12.6%，p = 0.044）。昂丹司琼组严重恶心发生率为14.4%，氟哌利多组为15.4%，差异无统计学意义（p = 1.00）。两组在任何恶心发生率（p = 0.434）或不良反应发生率（p = 0.220）上均未观察到显著差异。我们计算得出，氟哌利多和茶苯海明联合使用的成本比昂丹司琼治疗方案低7倍。
在本研究中，对于接受斜视手术的儿童，静脉注射氟哌利多后口服茶苯海明的疗效和安全性与静脉注射昂丹司琼后口服昂丹司琼并无差异。由于昂丹司琼治疗的成本远高于氟哌利多和茶苯海明联合使用，如果考虑所有其他变量，此时在该人群中使用昂丹司琼预防和治疗呕吐和恶心在成本方面可能并无益处。
