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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed National Military Medical Center
• Treatments: Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• 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 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