Comparison Trial of Enema vs. PEG 3350 for Constipation
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | December 2006 |
End Date: | December 2008 |
Contact: | Melissa K Miller, MD |
Email: | mmiller@cmh.edu |
Phone: | 816.234.3665 |
Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation
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.
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.
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
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