NCT00467350

Comparison Trial of Enema vs. PEG 3350 for Constipation

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	PEG 3350	PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
DRUG	milk and molasses enema	enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-04-30
• Last updated: 2020-11-02
• Results posted: 2020-11-02

Locations

1 site across 1 country: United States