Comparison Trial of Enema vs. PEG 3350 for Constipation

Constipation Clinical Trial

Official title:

Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00467350
• Other study ID #: 06-07-117
• Status: Terminated
• Phase: N/A
• Start date: December 2006
• Est. completion date: May 2009

Study information

• Verified date: October 2020
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 17 Years

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

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• PEG 3350
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
• milk and molasses enema
enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With Main Symptom Improvement	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?"	5 days