跳至主要内容
临床试验/NCT02473887
NCT02473887已完成1 期

Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

Hamad Medical Corporation0 个研究点目标入组 40 人开始时间: 2014年9月最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
主要终点
ondansetron serum level.

研究概览

简要总结

The purpose of this study is to give children with gastroenteritis with persistent vomiting flavored intravenous ondansetron orally. The investigators test the palatability of the drug and check the serum level of ondansetron at 4 hours .

详细描述

This is a prospective pilot study for children,3-8 years of age presented to the Pediatric Emergency Department in the state of Qatar between September 2014 and January 2015, with acute gastroenteritis with mild to moderate dehydration, more than 2 episodes of vomiting in the last 24 hours, and who had failed oral rehydration trial in the department as per the department oral hydration protocol. Acute gastroenteritis was defined as diarrhea and vomiting for less than a week period.

Hydration level was assessed for all patients on arrival, and eligible patients were enrolled after obtaining an informed written consent.Enrolled patients received intravenous ondansetron form orally after being flavored 1:1 with ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight. Palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. All patients were kept nil per oral for 30 minutes and then oral rehydration trial was started as per the department rehydration protocol. If the drug was vomited within 30 min of administration, a similar second dose was given. Blood level for ondansetron was collected 4 hours after the successful drug administration and was sent to the department laboratory within 5 min. Patients were sent home when they were ready for discharge as per the treating physician discretion. All patients were followed by a telephone call after 24 hours to assess the safety and efficacy of the orally taken ondansetron.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children 3-8 years of age.
  • acute simple gastroenteritis with mild to moderate dehydration.
  • more than 2 episodes of vomiting in 24 hours period.

排除标准

  • known hypersensitivity to ondansetron.
  • seizure disorder.
  • chronic liver or kidney diseases.
  • on any chronic medication.

结局指标

主要结局

ondansetron serum level.

时间窗: 4 hour

serum level of ondansetron at 4 hours after drug administration.

次要结局

  • palatability score of the drug.score 3/5( not sure to like very much ).(within one minute from drug administration.)

研究者

申办方类型
Industry
责任方
Sponsor

相似试验