Comparison Trial of Enema vs. PEG 3350 for Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00467350
Recruitment Status : Terminated (concern patients in oral cleaout arm had worse outcome)
First Posted : April 30, 2007
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
Melissa Miller, Children's Mercy Hospital Kansas City

Brief Summary:
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 or disease Intervention/treatment Phase
Constipation Drug: PEG 3350 Drug: milk and molasses enema Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation
Study Start Date : December 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00467350

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

Responsible Party: Melissa Miller, Assistant Professor, Children's Mercy Hospital Kansas City Identifier: NCT00467350     History of Changes
Other Study ID Numbers: 06-07-117
First Posted: April 30, 2007    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Melissa Miller, Children's Mercy Hospital Kansas City:
fecal impaction

Additional relevant MeSH terms:
Fecal Impaction
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Polyethylene glycol 3350
Gastrointestinal Agents