Examining the Effect of Ondansetron on Bowel Prep Success

Phase 4

Completed

• Conditions: Abdominal Pain; Diarrhea; Weight Loss; Eosinophilic Gastroenteritis; Inflammatory Bowel Diseases; Hematochezia
• Interventions: Drug: Ondansetron

• Registration Number: NCT05439772
• Lead Sponsor: State University of New York - Downstate Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-06-30
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

• known arrhythmia or long QT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron	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.

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Scale	24 hours after dose	validated scoring system of bowel preparation

Secondary Outcome Measures

Name	Time	Method
Symptoms associated with Bowel Prep	24 hours after dose	assess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation

Trial Locations

Locations (1)

SUNY Downstate University Hospital of Brooklyn; 🇺🇸 Brooklyn, New York, United States