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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | |
| Ondansetron | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Boston Bowel Preparation Scale | validated scoring system of bowel preparation | 24 hours after dose |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Wallach, MD | SUNY Downstate HSU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Downstate University Hospital of Brooklyn | Brooklyn | New York | 11203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38034452 | Derived | Arostegui D, Armaly P, Castro Ochoa K, Lemus VV, Peshimam J, Sharma S, Schwarz S, Wallach T. Pilot Study of Ondansetron in Improvement of Pediatric Colonoscopy Preparation Outcomes at an Urban Academic Center. JPGN Rep. 2023 Sep 8;4(4):e366. doi: 10.1097/PG9.0000000000000366. eCollection 2023 Nov. |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D015212 | Inflammatory Bowel Diseases |
| C535952 | Eosinophilic enteropathy |
| D003967 | Diarrhea |
| D006471 | Gastrointestinal Hemorrhage |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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non-blinded randomized control trial
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| D012817 | Signs and Symptoms, Digestive |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |