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

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.

Study Overview

• Status: Terminated
• Conditions: Constipation
• Intervention / Treatment: Drug: milk and molasses enema; Drug: PEG 3350

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: enema; Rectal enema containing mixture of milk and molasses	Drug: milk and molasses enema; enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance; Other Names: enema
Active Comparator: PEG 3350; Medication to be taken orally once each day for three consecutive days	Drug: PEG 3350; PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance; Other Names: Miralax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Melissa K Miller, MD, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 26, 2007
• First Submitted That Met QC Criteria: April 27, 2007
• First Posted (Estimate): April 30, 2007

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: treatment; pediatric; constipation; fecal impaction
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: 06-07-117