Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children

NCT ID: NCT01518790

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-08-31

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 performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep 2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the cleanout, assess tolerability and acceptance of the regimen, determine an appropriate duration to complete the regimen and assess for any electrolyte changes or side effects.

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 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.

Conditions

Colonoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Polyethylene glycol 3350

Group Type: EXPERIMENTAL

polyethylene glycol 3350

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Miralax

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mazen I Abbas, DO, MPH

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

References

Abbas MI, Nylund CM, Bruch CJ, Nazareno LG, Rogers PL. Prospective evaluation of 1-day polyethylene glycol-3350 bowel preparation regimen in children. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):220-4. doi: 10.1097/MPG.0b013e31826630fc.

Reference Type: DERIVED

PMID: 22744195 (View on PubMed)

Other Identifiers

353750

Identifier Type: -

Identifier Source: org_study_id