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Examining the Effect of Ondansetron on Bowel Prep Success

Primary Purpose

Abdominal Pain, Inflammatory Bowel Diseases, Eosinophilic Gastroenteritis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Sponsored by
State University of New York - Downstate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Pain focused on measuring colonoscopy, bowel preparation, ondansetron

Eligibility Criteria

2 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >2, <20
  • clinically indicated for a colonoscopy

Exclusion Criteria:

  • known arrhythmia or long QT

Sites / Locations

  • SUNY Downstate University Hospital of BrooklynRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Ondansetron

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Boston Bowel Preparation Scale
validated scoring system of bowel preparation

Secondary Outcome Measures

Symptoms associated with Bowel Prep
assess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation

Full Information

First Posted
June 23, 2022
Last Updated
June 28, 2022
Sponsor
State University of New York - Downstate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05439772
Brief Title
Examining the Effect of Ondansetron on Bowel Prep Success
Official Title
Examining the Effect of Ondansetron on Bowel Prep Success
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Downstate Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Inflammatory Bowel Diseases, Eosinophilic Gastroenteritis, Diarrhea, Hematochezia, Weight Loss
Keywords
colonoscopy, bowel preparation, ondansetron

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
non-blinded randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.
Primary Outcome Measure Information:
Title
Boston Bowel Preparation Scale
Description
validated scoring system of bowel preparation
Time Frame
24 hours after dose
Secondary Outcome Measure Information:
Title
Symptoms associated with Bowel Prep
Description
assess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation
Time Frame
24 hours after dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >2, <20 clinically indicated for a colonoscopy Exclusion Criteria: known arrhythmia or long QT
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Wallach, MD
Phone
718-270-1313
Email
thomas.wallach@downstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia Arostegui, MD
Email
dalia.arostegui@downstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Wallach, MD
Organizational Affiliation
SUNY Downstate HSU
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Downstate University Hospital of Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Wallach, MD
Phone
718-270-1313
Email
thomas.wallach@downstate.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Examining the Effect of Ondansetron on Bowel Prep Success

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