Comparison Trial of Enema vs. PEG 3350 for Constipation
This study has been terminated.
(concern patients in oral cleaout arm had worse outcome)
Sponsor:
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
Melissa Miller, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00467350
First received: April 26, 2007
Last updated: February 13, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Constipation |
Drug: PEG 3350 Drug: milk and molasses enema |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation |
Resource links provided by NLM:
Further study details as provided by Children's Mercy Hospital Kansas City:
Primary Outcome Measures:
- To compare the efficacy of milk and molasses enema vs. PEG 3350 for global improvement of symptoms in children with fecal impaction and constipation [ Time Frame: two years ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | December 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: enema |
Drug: milk and molasses enema
enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
|
| Active Comparator: PEG 3350 |
Drug: PEG 3350
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
|
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.
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467350
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467350
Locations
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
| Principal Investigator: | Melissa K Miller, MD | Children's Mercy Hospital |
More Information
| Responsible Party: | Melissa Miller, Assistant Professor, Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT00467350 History of Changes |
| Other Study ID Numbers: | 06-07-117 |
| Study First Received: | April 26, 2007 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Mercy Hospital Kansas City:
|
constipation treatment fecal impaction pediatric |
Additional relevant MeSH terms:
|
Constipation Fecal Impaction Signs and Symptoms, Digestive Signs and Symptoms Intestinal Obstruction Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Polyethylene glycol 3350 Laxatives Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 30, 2016