Comparison Trial of Enema vs. PEG 3350 for Constipation

Stopped early · Not applicable

Conditions studied: Constipation

In brief

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.

Key facts

Study ID: NCT00467350
Run by: Children's Mercy Hospital Kansas City
People needed: 80
Starts: 2006-12-01
Expected to finish: 2009-05-01
Last updated by the study team: 2020-11-02

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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