Examining the Effect of Ondansetron on Bowel Prep Success

Inflammatory Bowel Diseases Clinical Trial

Official title:

Examining the Effect of Ondansetron on Bowel Prep Success

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05439772
• Other study ID #: 1650686-6
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Pain
• Diarrhea
• Eosinophilic Esophagitis
• Eosinophilic Gastroenteritis
• Gastroenteritis
• Gastrointestinal Hemorrhage
• Hematochezia
• Inflammatory Bowel Diseases
• Weight Loss

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