Back to resultsComparison Trial of Enema vs. PEG 3350 for Constipation
Primary Purpose
Constipation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEG 3350
milk and molasses enema
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring constipation, treatment, fecal impaction, pediatric
Eligibility 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
Sites / Locations
- Children's Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
enema
PEG 3350
Arm Description
Rectal enema containing mixture of milk and molasses
Medication to be taken orally once each day for three consecutive days
Outcomes
Primary Outcome Measures
The Number of Participants With Main Symptom Improvement
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?"
Secondary Outcome Measures
Full Information
NCT ID
NCT00467350
First Posted
April 26, 2007
Last Updated
October 9, 2020
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT00467350
Brief Title
Comparison Trial of Enema vs. PEG 3350 for Constipation
Official Title
Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
concern patients in oral cleaout arm had worse outcome
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, treatment, fecal impaction, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
enema
Arm Type
Active Comparator
Arm Description
Rectal enema containing mixture of milk and molasses
Arm Title
PEG 3350
Arm Type
Active Comparator
Arm Description
Medication to be taken orally once each day for three consecutive days
Intervention Type
Drug
Intervention Name(s)
PEG 3350
Other Intervention Name(s)
Miralax
Intervention Description
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
Intervention Type
Drug
Intervention Name(s)
milk and molasses enema
Other Intervention Name(s)
enema
Intervention Description
enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
Primary Outcome Measure Information:
Title
The Number of Participants With Main Symptom Improvement
Description
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?"
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa K Miller, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison Trial of Enema vs. PEG 3350 for Constipation
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