Comparison Trial of Enema vs. PEG 3350 for Constipation

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
enema	milk and molasses enema	Rectal enema containing mixture of milk and molasses
PEG 3350	PEG 3350	Medication to be taken orally once each day for three consecutive days

Primary Outcome Measures

Name	Time	Method
The Number of Participants With Main Symptom Improvement	5 days	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