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Completed

NCT Number: NCT05439772

Examining the Effect of Ondansetron on Bowel Prep Success

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.

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Key information

Conditions

Abdominal Pain Body Weight Body Weight Changes Diarrhea Digestive System Diseases Eosinophilic Gastroenteritis Eosinophilic enteropathy Gastroenteritis Gastrointestinal Diseases Gastrointestinal Hemorrhage Hematochezia Hemorrhage Inflammatory Bowel Diseases Intestinal Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Weight Loss

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SUNY Downstate University Hospital of Brooklyn

Brooklyn, New York, 11203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • known arrhythmia or long QT

Treatment and study plan

ondansetron

Drug

Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.

Other names: Zofran

Primary outcomes

  1. Boston Bowel Preparation Scale

    Time frame: 24 hours after dose

    validated scoring system of bowel preparation

Secondary outcomes

  1. Symptoms associated with Bowel Prep

    Time frame: 24 hours after dose

    assess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation

Sponsors and collaborators

Lead sponsor

State University of New York - Downstate Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2022
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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