An interventional study of PEG 3350 and milk and molasses enema in Constipation, sponsored by Children's Mercy Hospital Kansas City. Terminated at 1 site in United States. Open to participants aged 1 Year to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-02.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Treatment
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.
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Constipated children who have one of the following three conditions:
Exclusion Criteria:
Rectal enema containing mixture of milk and molasses
Drug: milk and molasses enema
Medication to be taken orally once each day for three consecutive days
Drug: PEG 3350
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
Also known as: Miralax
enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
Also known as: enema
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
A convenience sample of patients aged 1 to 17 years was recruited between December 2006 and May 2009 from a pediatric emergency department.
| Milestone | Enema | PEG 3350 |
|---|---|---|
| Started | 41 | 39 |
| Completed | 40 | 39 |
| Not completed | 1 | 0 |
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?"
| Participants | Enema | PEG 3350 |
|---|---|---|
| The Number of Participants With Main Symptom Improvement | 28 | 22 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enema | 0/40 (0%) | 0/40 (0%) | 1/40 (2.5%) |
| PEG 3350 | 0/39 (0%) | 0/39 (0%) | 4/39 (10.3%) |
| Event | Enema | PEG 3350 |
|---|---|---|
| treatment failureGastrointestinal disorders | 1/40 | 4/39 |
| Age, Continuous(years) | Enema | PEG 3350 | Total |
|---|---|---|---|
| Mean | 6.8 ± 0.7 | 6.9 ± 0.7 | 6.9 ± 0.5 |
| Sex: Female, Male(Participants) | Enema | PEG 3350 | Total |
|---|---|---|---|
| Female | 26 | 20 | 46 |
| Male | 14 | 19 | 33 |
| Race/Ethnicity, Customized(Participants) | Enema | PEG 3350 | Total |
|---|---|---|---|
| White | 12 | 18 | 30 |
| African American | 17 | 14 | 31 |
| Hispanic | 6 | 5 | 11 |
| other | 5 | 2 | 7 |
| Region of Enrollment(Participants) | Enema | PEG 3350 | Total |
|---|---|---|---|
| United States | 40 | 39 | 79 |
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Children's Mercy Hospital Kansas City