Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Drug: PEG-Lyte®; Drug: Pico-Salax®

• Registration Number: NCT00380497
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before colonoscopy in children, and to compare effectiveness.

Detailed Description

Good bowel cleanout before colonoscopy is commonly associated with significant discomfort that children do not tolerate well. Many pediatric centers in North America use Poly-Ethylene Glycol and electrolyte solution (PEG-ELS, Golytely®) for bowel lavage administered in a large volume, often causing nausea, vomiting and bloating. This is often poorly tolerated by children who usually require the insertion of a nasogastric tube and a day admission. Recently, Pico-Salax was approved in Canada for bowel cleanout in children. It is administered in two divided doses, each in one cup of water; it is palatable and does not have to be given in hospital. However, no controlled study in children compared it with the current standard of care. Our preliminary experience and previous literature suggest that it is effective and well tolerated. We propose to study whether colon cleanout for colonoscopy with Pico-Salax is better tolerated than Golytely in children, by a single blinded randomized controlled trial. Positive results of this study will facilitate a better tolerated regimen for bowel clean out in children.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-25
• Study First Submitted QC: 2006-09-25
• Study First Posted: 2006-09-26
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-25
• Last Update Posted: 2013-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Children between 4 and 18 years of age
• Undergoing full elective ambulatory colonoscopy

Read More

Exclusion Criteria

• Evidence of bowel obstruction, prior partial or total colectomy and significant renal failure (GFR<50 mls/min/1.73 m2)
• Second dose of Pico-Salax will not be given to children with blood pressure less than the tenth percentile or pulse rate >90th% of normal reference value for age, or in children with a clinical need for bolus IV fluids decided by the clinical fellow

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEGlyte	PEG-Lyte®	-
Pico-Salax	Pico-Salax®	-

Primary Outcome Measures

Name	Time	Method
Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents

Secondary Outcome Measures

Name	Time	Method
Side effects (measured by: dehydration assessment, questionnaires completed by the nurse and the patient, and blood tests)
Cleanout effectiveness (measured by: rating of a blinded gastroenterologist, the need for enema supplement, procedure length and whether the planned destination was reached

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada