Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00467350
Recruitment Status : Terminated (concern patients in oral cleaout arm had worse outcome)
First Posted : April 30, 2007
Results First Posted : November 2, 2020
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Melissa Miller, Children's Mercy Hospital Kansas City

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

MedlinePlus related topics: Constipation

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: enema
Rectal enema containing mixture of milk and molasses
 Drug: milk and molasses enema
enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
Other Name: enema
Active Comparator: PEG 3350
Medication to be taken orally once each day for three consecutive days
 Drug: PEG 3350
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
Other Name: Miralax


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The Number of Participants With Main Symptom Improvement [ Time Frame: 5 days ]
    On day 5, the number of participants who respond "improved" to the question "Has your child's main symptom improved, stayed the same or gotten worse?"


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00467350


Locations
Layout table for location information
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Layout table for investigator information
Principal Investigator: Melissa K Miller, MD Children's Mercy Hospital Kansas City
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Melissa Miller, Assistant Professor, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00467350    
Other Study ID Numbers: 06-07-117
First Posted: April 30, 2007    Key Record Dates
Results First Posted: November 2, 2020
Last Update Posted: November 2, 2020
Last Verified: October 2020
Keywords provided by Melissa Miller, Children's Mercy Hospital Kansas City:
constipation
treatment
fecal impaction
pediatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Constipation
Signs and Symptoms, Digestive
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents