Examining the Effect of Ondansetron on Bowel Prep Success

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: January 1, 2024

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.

Interventions

• Drug: Ondansetron
  • Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.

Arms, Groups and Cohorts

• No Intervention: Control
  • 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
• Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

• Boston Bowel Preparation Scale
  • Time Frame: 24 hours after dose
  • validated scoring system of bowel preparation

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

• Age >2, <20 – clinically indicated for a colonoscopy Exclusion Criteria:

• known arrhythmia or long QT

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 20 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • State University of New York – Downstate Medical Center
• Provider of Information About this Clinical Study
  • Principal Investigator: Thomas Wallach, Assistant Professor of Pediatrics – State University of New York – Downstate Medical Center
• Overall Official(s)
  • Thomas Wallach, MD, Principal Investigator, SUNY Downstate HSU
• Overall Contact(s)
  • Thomas Wallach, MD, 718-270-1313, thomas.wallach@downstate.edu