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concern patients in oral cleaout arm had worse outcome
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enema | Active Comparator | Rectal enema containing mixture of milk and molasses |
|
| PEG 3350 | Active Comparator | Medication to be taken orally once each day for three consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG 3350 | Drug | PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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?" | 5 days |
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Inclusion Criteria:
Constipated children who have one of the following three conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa K Miller, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
There were no significant events that occurred after enrollment and before study arm assignment.
A convenience sample of patients aged 1 to 17 years was recruited between December 2006 and May 2009 from a pediatric emergency department.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enema | milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance |
| FG001 | PEG 3350 | PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | PEG 3350 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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?" | Posted | Count of Participants | Participants | 5 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enema | milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| treatment failure | Gastrointestinal disorders | Systematic Assessment |
More than half of patients who were approached declined participation. A moderate number of patients (29%) were lost to follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Miller MD | Children's Mercy Hospitals and Clinics | 8162343000 | mmiller@cmh.edu |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D005244 | Fecal Impaction |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007415 | Intestinal Obstruction |
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| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
| D008892 | Milk |
| D004733 | Enema |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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| milk and molasses enema | Drug | enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance |
|
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 1 |
| 40 |
| EG001 | PEG 3350 | PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance | 0 | 39 | 0 | 39 | 4 | 39 |
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| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005502 |
| Food |
| D019602 | Food and Beverages |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |