Constipation
Conditions
Keywords
constipation, treatment, fecal impaction, pediatric
Brief summary
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
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.
Interventions
DRUGPEG 3350
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
DRUGmilk and molasses enema
enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Main Symptom Improvement | 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? |
Countries
United States
Participant flow
Recruitment details
A convenience sample of patients aged 1 to 17 years was recruited between December 2006 and May 2009 from a pediatric emergency department.
Pre-assignment details
There were no significant events that occurred after enrollment and before study arm assignment.
Participants by arm
| Arm | Count |
|---|---|
| Enema Rectal enema containing mixture of milk and molasses
milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance | 40 |
| PEG 3350 Medication to be taken orally once each day for three consecutive days
PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance | 39 |
| Total | 79 |
Baseline characteristics
| Characteristic | Enema | PEG 3350 | Total |
|---|---|---|---|
| Age, Continuous | 6.8 years STANDARD_DEVIATION 0.7 | 6.9 years STANDARD_DEVIATION 0.7 | 6.9 years STANDARD_DEVIATION 0.5 |
| Race/Ethnicity, Customized African American | 17 Participants | 14 Participants | 31 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized other | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 18 Participants | 30 Participants |
| Region of Enrollment United States | 40 Participants | 39 Participants | 79 Participants |
| Sex: Female, Male Female | 26 Participants | 20 Participants | 46 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 39 |
| other Total, other adverse events | 1 / 40 | 4 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 |
Outcome results
Primary
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?
Time frame: 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enema | The Number of Participants With Main Symptom Improvement | 28 Participants |
| PEG 3350 | The Number of Participants With Main Symptom Improvement | 22 Participants |