Examining the Effect of Ondansetron on Bowel Prep Success

Study Overview
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Brief Summary
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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
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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.

Official Title
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Examining the Effect of Ondansetron on Bowel Prep Success

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

Intervention / Treatment
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* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >2, <20 clinically indicated for a colonoscopy Exclusion Criteria: known arrhythmia or long QT

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-blinded randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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. | Drug: Ondansetron<br>* Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Scale | validated scoring system of bowel preparation | 24 hours after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms associated with Bowel Prep | assess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation | 24 hours after dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, bowel preparation, ondansetron