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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
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: enema 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: PEG 3350 Drug: PEG 3350
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance

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

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Melissa K Miller, MD Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Melissa Miller, Assistant Professor, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00467350     History of Changes
Other Study ID Numbers: 06-07-117
Study First Received: April 26, 2007
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Constipation
Fecal Impaction
Signs and Symptoms, Digestive
Signs and Symptoms
 Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013