Comparison Trial of Enema vs. PEG 3350 for Constipation

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Treatments: Polyethylene glycol 3350

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
• 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