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Comparison Trial of Enema vs. PEG 3350 for Constipation

NCT ID: NCT00467350

Last Updated: 2020-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-05-31

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.

Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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enema

Rectal enema containing mixture of milk and molasses

Group Type ACTIVE_COMPARATOR

milk and molasses enema

Intervention Type DRUG

enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance

PEG 3350

Medication to be taken orally once each day for three consecutive days

Group Type ACTIVE_COMPARATOR

PEG 3350

Intervention Type DRUG

PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance

Interventions

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PEG 3350

PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance

Intervention Type DRUG

milk and molasses enema

enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance

Intervention Type DRUG

Other Intervention Names

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Miralax enema

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Melissa Miller

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa K Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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06-07-117

Identifier Type: -

Identifier Source: org_study_id