Comparison Trial of Enema vs. PEG 3350 for Constipation

This study has been terminated.
(concern patients in oral cleaout arm had worse outcome)
Sponsor:
Information provided by (Responsible Party):
Melissa Miller, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00467350
First received: April 26, 2007
Last updated: February 13, 2013
Last verified: February 2013

April 26, 2007
February 13, 2013
December 2006
May 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00467350 on ClinicalTrials.gov Archive Site
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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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Constipation
  • Drug: PEG 3350
    PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
  • Drug: milk and molasses enema
    enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
  • Active Comparator: enema
    Intervention: Drug: milk and molasses enema
  • Active Comparator: PEG 3350
    Intervention: Drug: PEG 3350
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
May 2009
May 2009   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
United States
 
NCT00467350
06-07-117
No
Melissa Miller, Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
Not Provided
Principal Investigator: Melissa K Miller, MD Children's Mercy Hospital
Children's Mercy Hospital Kansas City
February 2013

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