Comparison Trial of Enema vs. PEG 3350 for Constipation (NCT00467350) | Clinical Trial Compass
TerminatedNot Applicable
Comparison Trial of Enema vs. PEG 3350 for Constipation
Stopped: concern patients in oral cleaout arm had worse outcome
United States80 participantsStarted 2006-12
Plain-language 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.
Who can participate
Age range1 Year – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The Number of Participants With Main Symptom Improvement