Clinical trial NCT00380497: Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children
Official title: Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in children-a Single Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: Pediatrics
Colonoscopy
Bowel cleanout
Poly-Ethylene Glycol
Pico-Salax
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2006-09-26
Enrollment: 83
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents
Secondary outcomes:
measure: Cleanout effectiveness (measured by: rating of a blinded gastroenterologist, the need for enema supplement, procedure length and whether the planned destination was reached
measure: Side effects (measured by: dehydration assessment, questionnaires completed by the nurse and the patient, and blood tests)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Simon Ling, MD
role: PRINCIPAL_INVESTIGATOR
References: