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Examining the Effect of Ondansetron on Bowel Prep Success

Examining the Effect of Ondansetron on Bowel Prep Success

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05439772
Enrollment
41
Registered
2022-06-30
Start date
2021-01-01
Completion date
2023-07-01
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Diarrhea, Eosinophilic Gastroenteritis, Hematochezia, Inflammatory Bowel Diseases, Weight Loss

Keywords

colonoscopy, bowel preparation, ondansetron

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.

Interventions

DRUGOndansetron

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

Sponsors

State University of New York - Downstate Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

non-blinded randomized control trial

Eligibility

Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* Age \>2, \<20 * clinically indicated for a colonoscopy

Exclusion criteria

* known arrhythmia or long QT

Design outcomes

Primary

MeasureTime frameDescription
Boston Bowel Preparation Scale24 hours after dosevalidated scoring system of bowel preparation

Secondary

MeasureTime frameDescription
Symptoms associated with Bowel Prep24 hours after doseassess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026