Comparison Trial of Enema vs. PEG 3350 for Constipation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Constipation

Intervention / Treatment
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* Drug: PEG 3350
* Drug: milk and molasses enema


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, treatment, fecal impaction, pediatric