Status:
COMPLETED
Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Colonoscopy
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
The investigators propose to conduct a prospective study of a widely used bowel preparation regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a colonoscopy performe...
Detailed Description
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 standardize...
Eligibility Criteria
Inclusion
- Male and female DEERS-eligible dependent military health care beneficiaries age 8 to 18 years old evaluated by Pediatric Gastroenterology service at WRAMC and are scheduled to undergo a colonoscopy between 1 Sep 2010 - 31 Dec 2011 and do not meet exclusion criteria.
Exclusion
- Age less than 8 years or greater than 18 at time of procedure
- Colonic surgery including hemicolectomy, colectomy, ileostomy, or multiple abdominal surgeries.
- Oral aversion or other feeding disorder.
- Inability to drink large amount of liquids.
- Aspiration risk.
- Renal disease or pre-cleanout electrolytes outside normal range.
- Significant cardiovascular disease.
- Allergy to food coloring or polyethylene glycol 3350.
- Inpatient or emergency colonoscopy.
- Current nasogastric tube in place.
- Known Pregnancy. Urine pregnancy test will only be completed on day of colonoscopy for all females age 14 and older per current standard anesthesia protocols. There have been no known reported animal or human studies that report the fetal effects of using polyethylene glycol. Per FDA, it is labeled as a category C drug in pregnancy. However, two studies , have reported successful treatment of constipation during pregnancy using polyethylene glycol solutions and did not find any significant effects or safety issues
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01518790
Start Date
September 1 2010
End Date
August 1 2011
Last Update
February 10 2016
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814