Bowel Preparation for Colonoscopy in Children - Full Text View

Purpose

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

Condition	Intervention	Phase
Colonoscopy Preparation	Drug: polyethylene glycol, senna	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator)
Official Title:	Polyethylene Glycol Powder Solution vs Senna for Bowel Preparation for Colonoscopy in Children: A Prospective, Randomized, Investigator-Blinded Trial.

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy

Drug Information available for: Sennoside A Sennoside B Sennoside Polyethylene Polyethylene glycol

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

Efficacy of Colon Preparation [ Time Frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation ] [ Designated as safety issue: No ]
Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.

Secondary Outcome Measures:

Proportion of Patients With Abnormal Electrolyte Levels [ Time Frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation ] [ Designated as safety issue: Yes ]
The outcome measure was comparison of the proportions of patients who had abnormal electrolyte levels between two groups of patients, Miralax and senna.

Sodium, potassium, chloride, and carbon dioxide levels were measured in mmol/L while urea nitrogen, creatinine, glucose, calcium, magnesium, and phosphorus were measured in mg/dL. Each of these values has a reference range which varies with patients' age and sex. Minimal change of one point above or below normal reference range was dismissed as clinically insignificant. Abnormal creatinine levels were rechecked through glomerular filtration rate calculation to determine if there was any compromise in renal function since abnormal creatinine level does not mean there is renal dysfunction nor that the level is clinically significant.

Enrollment:	33
Study Start Date:	September 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1, Miralax Miralax colonoscopy preparation	Drug: polyethylene glycol, senna Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure. Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days. Other Names: Miralax Senna
Active Comparator: 2, senna Senna colonoscopy preparation	Drug: polyethylene glycol, senna Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure. Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days. Other Names: Miralax Senna

Arms

Assigned Interventions

Active Comparator: 1, Miralax

Miralax colonoscopy preparation

Drug: polyethylene glycol, senna

Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.

Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days.

Other Names:

Miralax
Senna

Active Comparator: 2, senna

Senna colonoscopy preparation

Drug: polyethylene glycol, senna

Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.

Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days.

Other Names:

Miralax
Senna

Detailed 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).

Eligibility

Ages Eligible for Study:	6 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140295

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

Principal Investigator:

Petar Mamula, MD

Children's Hospital of Philadelphia

More Information

No publications provided by Children's Hospital of Philadelphia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Terry NA, Chen-Lim ML, Ely E, Jatla M, Ciavardone D, Esch S, Farace L, Jannelli F, Puma A, Carlow D, Mamula P. Polyethylene glycol powder solution versus senna for bowel preparation for colonoscopy in children. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):215-9. doi: 10.1097/MPG.0b013e3182633d0a.

Responsible Party:	Petar Mamula, Director, Endoscopy, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT01140295 History of Changes
Other Study ID Numbers:	2006-10-5004
Study First Received:	June 1, 2010
Results First Received:	December 12, 2012
Last Updated:	April 10, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:

Preparation
Pediatric
Colonoscopy

Additional relevant MeSH terms:

Senna Extract
Sennoside A&B
Cathartics

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013