A randomized clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis

作     者：Ramsook, C Sahagun-Carreon, I Kozinetz, CA Moro-Sutherland, D 

作者机构：Wendy Fitzwilliam Pediat Hosp Sect Pediat Emergency Med Mt Hope Trinidad Tobago Texas Childrens Hosp Baylor Coll Med Dept Pediat Sect Emergency Med Houston TX 77030 USA Texas Childrens Hosp Baylor Coll Med Dept Pediat Sect Acad Gen Pediat Houston TX 77030 USA 

出 版 物：《ANNALS OF EMERGENCY MEDICINE》 (急救医学纪事)

年 卷 期：2002年第39卷第4期

页      面：397-403页

核心收录：

学科分类：1002[医学-临床医学] 10[医学] 

基　　金：GlaxoWellcome Research and Development 

主　　题：急性病/治疗 投药 口服 腹泻/并发症 双盲法 补液疗法/统计学和数值数据 胃肠炎/并发症 住院/统计学和数值数据 昂丹司琼/投药和剂量 前瞻性研究 治疗结果 呕吐/药物疗法 呕吐/病因学 儿童 儿童 学龄前 女(雌)性 人类 婴儿 男(雄)性 

摘      要：Study objective: Vomiting in children suffering from acute gastroenteritis interferes with the oral rehydration process and equally frustrates parents and health care providers. Adjuncts such as promethazine and metoclopramide are less than optimally effective and are associated with side effects. Ondansetron, a 5-HT3 receptor antagonist marketed as Zofran, is a safe and effective antiemetic used extensively in oncology and postoperative patients. We evaluate the effect of the antiemetic ondansetron versus placebo on the clinical outcome of patients with vomiting from gastroenteritis in a pediatric emergency department. Methods: This was a randomized, prospective, double-blind clinical trial in a university-affiliated children s hospital ED, Children between the ages of 6 months and 12 years who had vomited at least 5 times during the preceding 24 hours were randomized to receive either oral ondansetron or a taste- and color-matched placebo. Oral rehydration was commenced 15 minutes later at 5 mL/min per standard oral rehydration protocols. Patients were discharged after they voided and continued standard oral rehydration at home with the introduction of a bananas, rice, applesauce, and toast (BRAT) diet after the first 24 hours, Any patient requiring admission was considered a treatment failure, and no further doses were given. Discharged patients were given 5 additional doses to be used every 8 hours, and they were contacted by telephone 24 and 48 hours after discharge to record the number of episodes of vomiting and diarrhea. The parents were also required to complete a diary of the same information, which was mailed to the investigators for confirmation of the telephone data. Results: One hundred forty-five patients were enrolled, of whom 51% (n=74) were randomized to ondansetron. At baseline, age distribution, sex, and severity of illness did not differ between the ondansetron and placebo groups. During the observation period in the ED, the median number of epi