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Comparison Trial of Enema vs. PEG 3350 for Constipation
This study is currently recruiting participants.
Study NCT00467350   Information provided by Children's Mercy Hospital Kansas City
First Received: April 26, 2007   Last Updated: April 27, 2007   History of Changes

April 26, 2007
April 27, 2007
December 2006
 
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 ]
Same as current
Complete list of historical versions of study NCT00467350 on ClinicalTrials.gov Archive Site
 
 
 
Comparison Trial of Enema vs. PEG 3350 for Constipation
Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Constipation
  • Drug: PEG 3350
  • Drug: milk and molasses enema
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
140
December 2008
 

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
Both
1 Year to 17 Years
Yes
Contact: Melissa K Miller, MD 816.234.3665 mmiller@cmh.edu
United States
 
NCT00467350
 
06-07-117
Children's Mercy Hospital Kansas City
 
Principal Investigator: Melissa K Miller, MD Children's Mercy Hospital
Children's Mercy Hospital Kansas City
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP