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

Colonoscopy Clinical Trial

Official title:

Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in children-a Single Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380497
• Other study ID #: 1000008846
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2006
• Last updated: July 25, 2013
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: July 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children between 4 and 18 years of age

• Undergoing full elective ambulatory colonoscopy

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• PEG-Lyte®

• Pico-Salax®

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents
Secondary	Cleanout effectiveness (measured by: rating of a blinded gastroenterologist, the need for enema supplement, procedure length and whether the planned destination was reached
Secondary	Side effects (measured by: dehydration assessment, questionnaires completed by the nurse and the patient, and blood tests)