跳至主要内容
临床试验/NCT05439772
NCT05439772已完成4 期

Examining the Effect of Ondansetron on Bowel Prep Success

State University of New York - Downstate Medical Center1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Boston Bowel Preparation Scale

研究概览

简要总结

This is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.

详细描述

The study will compare two approaches to pre-colonoscopy cleanout, one with traditional laxatives only, and one with laxatives + anti-emetic therapy. The medication to be added will be Ondansetron (brand name: Zofran). Classically, the bowel prep entails drinking large amounts of water with an osmotic laxative and being only on a liquid diet the day prior to the procedure. Drinking this mixture of water with an osmotic laxative may cause nausea and discomfort in some patients that may prevent them from finishing the bowel prep. This will therefore affect the visualization of the colon during the procedure, as there will still be retained, hard stool. Having large amounts of stool in the colon during the procedure can make the colonoscopy more difficult, takes a longer time to complete, can make the study inconclusive, unable to properly diagnose, and difficult to take biopsies. This study assesses the impact of anti-emetic medication (ondansetron) on the bowel prep experience with the goal of improving participant tolerance and preparation success. This will eliminate concern for retained stool and less chance of cancelling a procedure due to improper bowel prep.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
2 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age >2, <20
  • clinically indicated for a colonoscopy

排除标准

  • known arrhythmia or long QT

研究组 & 干预措施

Ondansetron

Experimental

Pediatric patients between the ages of 2-20 who have a clinical indication for colonoscopy, who will undergo standard colonoscopy preparation of polyethylene glycol and bisacodyl with the addition of one dose of ondansetron prior to initiating bowel preparation.

干预措施: Ondansetron (Drug)

结局指标

主要结局

Boston Bowel Preparation Scale

时间窗: 24 hours after dose

validated scoring system of bowel preparation

次要结局

  • Symptoms associated with Bowel Prep(24 hours after dose)

研究者

发起方
State University of New York - Downstate Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Examining the Effect of Ondansetron on Bowel Prep... | 临床试验