Status:
TERMINATED
Comparison Trial of Enema vs. PEG 3350 for Constipation
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Constipation
Eligibility:
All Genders
1-17 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00467350
Start Date
December 1 2006
End Date
May 1 2009
Last Update
November 2 2020
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108