Bowel Preparation for Colonoscopy in Children

Children's Hospital of Philadelphia (CHOP)

Status and phase: Terminated; Phase 4

Conditions: Colonoscopy Preparation

Treatments: Drug: polyethylene glycol, senna

Study type: Interventional

Funder types: Other

Identifiers

NCT01140295

2006-10-5004

Details and patient eligibility

About

The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.

Full description

Study subjects will be randomized in two groups: Group one will receive 1.5 g/kg of Miralax orally the day before procedure and one day of clear liquid diet, while subjects in Group 2 will receive two doses of senna the day before procedure with two days of liquid diet (one day full liquid and one day clear liquid diet). On the day of the procedure parents/subjects will complete a questionnaire regarding prep compliance and adverse events. Electrolytes will be obtained prior to colonoscopy to monitor for electrolyte imbalance. Endoscopists will assess preparation for colonoscopy using validated cleanliness scale (Aronchick scale).

Enrollment: 33 patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects age 6-21 yrs for senna, PEG-P groups
2. Subjects age 13-21 yrs for NaP group
3. First time colonoscopy
4. Patient weight <70 kg for PEG-P group (to not exceed 51 grams/dose)

Exclusion criteria

1. Chronic renal, liver, or heart failure
2. Chronic constipation
3. Patients on the GI inpatient or consult service.
4. Subjects taking senna or PEG on a regular basis for laxative reasons.
5. Pregnant or lactating females

Trial design

33 participants in 2 patient groups

1, Miralax

Active Comparator group

Description:

Miralax colonoscopy preparation

Treatment:

Drug: polyethylene glycol, senna

2, senna

Active Comparator group

Description:

Senna colonoscopy preparation

Treatment:

Drug: polyethylene glycol, senna