Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children|
- Efficacy of Cleanout [ Time Frame: At the end of the colonoscopy within 10-18 hours of completing the cleanout ] [ Designated as safety issue: No ]Efficacy of cleanout utilizing Boston bowel preparation scale, completed by endoscopy fellow and staff at the end of the colonoscopy done within 10-18 hours after completion of the cleanout.
- Electrolyte changes assessing basic metabolic profiles pre/post cleanout [ Time Frame: 30 days prior to 1 day after cleanout ] [ Designated as safety issue: Yes ]BMP will be obtain within 30 days of cleanout and on the day of the colonoscopy at the time of IV insertion for anesthesia.
- Patient/parent satisfaction/tolerability/side effects utilizing questionnaire [ Time Frame: 1 day after cleanout ] [ Designated as safety issue: Yes ]Parents or patient fill out questionnaire on day of the colonoscopy
|Study Start Date:||September 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Experimental: Polyethylene glycol 3350||
Drug: polyethylene glycol 3350
PEG 3350 (238 grams) mixed with 1.9 L (64 oz) of Gatorade, given in 8 oz increments every 15-30 minutes until complete starting at 18:00 on day prior to colonoscopy (max time to completion 6 hours).
Other Name: Miralax
Purpose: It is hoped that by determining acceptability, safety and efficacy of this widely used short course, single-dose bowel preparation regimen, pediatric gastroenterologist can have a standardized bowel preparation for colonoscopy that will be acceptable to pediatric patients and their parents.
Research Design: This study is a prospective medication trial. It will utilize laboratory data to detect any electrolyte changes, a patient questionnaire to assess an acceptable duration, tolerance and side effects of the regimen. Efficacy of the cleanout will be assessed using a published standardized bowel preparation scale by the endoscopist at the completion of the colonoscopy.
Methodology /Technical Approach (including the number of subjects to be studied.): We estimate that 50 patients aged 8-18 years old military dependents who are undergoing a colonoscopy by the Pediatric Gastroenterology service at WRAMC/WRNMMC will be enrolled in the study between 1 Sep 2010 and 31 Dec 2011.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518790
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20814|
|Principal Investigator:||Mazen I Abbas, DO, MPH||Walter Reed National Military Medical Center|