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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pico-Salax

Group Type EXPERIMENTAL

Pico-Salax®

Intervention Type DRUG

PEGlyte

Group Type ACTIVE_COMPARATOR

PEG-Lyte®

Intervention Type DRUG

Interventions

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PEG-Lyte®

Intervention Type DRUG

Pico-Salax®

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No