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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05439772
Other study ID # 1650686-6
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2021
Est. completion date July 1, 2023

Study information

Verified date December 2023
Source State University of New York - Downstate Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 20 Years
Eligibility Inclusion Criteria: - Age >2, <20 - clinically indicated for a colonoscopy Exclusion Criteria: - known arrhythmia or long QT

Study Design


Intervention

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

Locations

Country Name City State
United States SUNY Downstate University Hospital of Brooklyn Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Boston Bowel Preparation Scale validated scoring system of bowel preparation 24 hours after dose
Secondary Symptoms associated with Bowel Prep assess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation 24 hours after dose
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