Comparison of Efficacy of Ondansetron Versus Metoclopramide for Vomiting in Children With Acute Gastroenteritis: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 250
- 主要终点
- Cumulative rate of vomiting after cessation of drug administration
研究概览
简要总结
Acute gastroenteritis (GEA) is a public health problem at present, the main cause of vomiting and consultation in emergencies in children under 5 years. Worldwide, there are about 2 million deaths per year due to gastroenteritis in children under 5 years.
In Mexico, the mortality rate by age in 2013, recorded 28 deaths per 100,000 boys and girls, in 2013 in our country 2.5 million children between 5 and 17 years engaged in an economic activity. The occupancy rate for the child population was 8.6: 11.4 for boys and 5.8 for girls.
NICE guidance gastroenteritis defined as a transient disorder caused by an enteric infection and characterized by a sudden onset of diarrhea with or without vomiting
详细描述
It will be conducted a randomized controlled double-blinded study in the Emergency service of the Naval General Hospital of High Specialty in the Mexico City. The period of patient inclusion in the study is November 2015 to November 2016.
The selections of the patients are children between 1 and 5 years who come to the emergency room with symptoms of acute gastroenteritis with vomiting and intolerance of oral route.
Treatments were randomly assigned eligible patients on admission in the emergency department
The primary endpoint was evaluated at 15 minutes after treatment application:
- Treatment 1: Ondansetron was administered intravenous dose (0.15mg/kg/doses) Diluted in 20 ml saline and administered intravenously 5 minutes
- Treatment 2: Metoclopramide was administered intravenous dose (0.15mg/kg/doses) Diluted in 20 ml saline and administered intravenously 5 minutes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Orally intolerance
- •More than 2 vomiting in the last 24 hours
- •Without antiemetic therapy within 24 hours of the clinical picture
- •Patients with or without diarrhea
排除标准
- •Previous abdominal surgery
- •Suspected surgical abdominal
- •Vomiting bile
- •Hypersensitivity to Ondansetron and Metoclopramide
研究组 & 干预措施
ondansetron
An intravenous dose of ondansetron ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes
干预措施: Ondansetron (Drug)
metoclopramide
An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes
干预措施: metoclopramide (Drug)
结局指标
主要结局
Cumulative rate of vomiting after cessation of drug administration
时间窗: 4 hours
次要结局
未报告次要终点