Comparison Trial of Enema vs. PEG 3350 for Constipation
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ClinicalTrials.gov Identifier: NCT00467350 |
Recruitment Status :
Terminated
(concern patients in oral cleaout arm had worse outcome)
First Posted : April 30, 2007
Results First Posted : November 2, 2020
Last Update Posted : November 2, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Constipation | Drug: PEG 3350 Drug: milk and molasses enema | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
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Active Comparator: enema
Rectal enema containing mixture of milk and molasses
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Drug: milk and molasses enema
enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
Other Name: enema |
Active Comparator: PEG 3350
Medication to be taken orally once each day for three consecutive days
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Drug: PEG 3350
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
Other Name: Miralax |
- The Number of Participants With Main Symptom Improvement [ Time Frame: 5 days ]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?"

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Ages Eligible for Study: | 1 Year to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467350
United States, Missouri | |
Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | Melissa K Miller, MD | Children's Mercy Hospital Kansas City |
Responsible Party: | Melissa Miller, Assistant Professor, Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00467350 |
Other Study ID Numbers: |
06-07-117 |
First Posted: | April 30, 2007 Key Record Dates |
Results First Posted: | November 2, 2020 |
Last Update Posted: | November 2, 2020 |
Last Verified: | October 2020 |
constipation treatment fecal impaction pediatric |
Constipation Signs and Symptoms, Digestive Polyethylene glycol 3350 Laxatives Gastrointestinal Agents |