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Comparison Trial of Enema vs. PEG 3350 for Constipation

This study is currently recruiting participants.
Verified by Children's Mercy Hospital Kansas City, April 2007

Sponsored by: Children's Mercy Hospital Kansas City
Information provided by: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00467350
  Purpose

The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.


Condition Intervention
Constipation
Drug: PEG 3350
Drug: milk and molasses enema

MedlinePlus related topics:   Constipation   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation

Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • To compare the efficacy of milk and molasses enema vs. PEG 3350 for global improvement of symptoms in children with fecal impaction and constipation [ Time Frame: two years ]

Estimated Enrollment:   140
Study Start Date:   December 2006
Estimated Study Completion Date:   December 2008

Detailed Description:

Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments.

Comparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation.

  Eligibility
Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Constipated children who have one of the following three conditions:

    • Fecal impaction (lower quadrant mass or dilated rectum with hard stool),
    • Functional fecal retention (large diameter stools as determined by caregiver <twice/week and retentive behaviors, or
    • Excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician

Exclusion Criteria:

  • Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)
  • Patients whose evaluation in the ED includes more than plain radiographs or urinalysis
  • Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)
  • Non-English speaking patients and families
  • Patients with milk allergy
  • Patients with molasses allergy
  • Patients who are pregnant
  • Patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery
  • Patients who are admitted to an in-patient unit
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467350

Contacts
Contact: Melissa K Miller, MD     816.234.3665     mmiller@cmh.edu    

Locations
United States, Missouri
Children's Mercy Hospital     Recruiting
      Kansas City, Missouri, United States, 64108
      Contact: Melissa K Miller, MD     816-234-3665     mmiller@cmh.edu    
      Principal Investigator: Melissa K Miller, MD            

Sponsors and Collaborators
Children's Mercy Hospital Kansas City

Investigators
Principal Investigator:     Melissa K Miller, MD     Children's Mercy Hospital    
  More Information


Study ID Numbers:   06-07-117
First Received:   April 26, 2007
Last Updated:   April 27, 2007
ClinicalTrials.gov Identifier:   NCT00467350
Health Authority:   United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
constipation  
treatment  
fecal impaction  
pediatric  

Study placed in the following topic categories:
Signs and Symptoms
Signs and Symptoms, Digestive
Constipation
Fecal Impaction

ClinicalTrials.gov processed this record on October 15, 2008




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