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NCT01823848 · ClinicalTrials.gov registry record · NA
A Trial of Three Types of Enemas Used to Treat Functional Constipation in Children
A NA study, sponsored by Children's Hospital Los Angeles.
- Terminated
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01823848 is a NA study that was terminated before completion, run by Children's Hospital Los Angeles. The registered enrollment target is 40 participants.
The verdict
NCT01823848, a NA study, was terminated before completion, sponsored by Children's Hospital Los Angeles.
- TERMINATED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Functional constipation is extremely common in children and is defined as painful, hard stools or firm stools for twice or less per week. Functional constipation accounts for 3% of general pediatric visits and up to 25% of pediatric gastroenterology visits. Constipation and fecal impaction can lead to a range of symptoms including decreased appetite, vomiting, and abdominal pain frequently resulting in Emergency Department (ED) presentation. In contrast to the outpatient setting where diet and oral medications work well to relieve symptoms related to functional constipation, ED management requires an approach with quicker results. For immediate relief of symptoms, disimpaction via enema use may be better than polyethylene glycol (PEG) 3350 for children. However, the type of enema to be used is not well studied. Currently, any patient presenting to the ED with a presumed diagnosis of abdominal pain due to functional constipation receives an oral dose of PEG and one of the following three types of enemas (based on the ED treating attending's discretion): phosphate or Fleets enema, normal saline enema, or mineral oil enema. There is no evidence in the literature that demonstrates any difference in the effectiveness of each of these enemas. The investigators propose a randomized control trial of the three types of pediatric enemas readily used in our ED to determine the best approach. There will be three arms within this study: a) PEG plus phosphate enema b) PEG plus normal saline enema and c) PEG plus mineral oil enema. The physicians enrolling patients will not be the treating physicians. The four principal investigators (blinded to the type of enema being used), following appropriate informed consent, will obtain pain scores (Faces Pain Scale - Revised) pre- and post-administration of each of the three treatments listed above in order to determine the best enema to use in children 4-12 years of age. Other outcomes to be analyzed will include the patient's weight pre-
Interventions
- DRUG Sodium phosphate enema
- DRUG Normal saline enema
- DRUG Mineral oil enema
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-04 |
| Est. Completion | 2017-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01823848
The ClinicalTrials.gov registry entry for NCT01823848 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sodium phosphate enema is the first listed.
NCT01823848 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01823848 about?
NCT01823848 is a clinical study titled "A Trial of Three Types of Enemas Used to Treat Functional Constipation in Children". Functional constipation is extremely common in children and is defined as painful, hard stools or firm stools for twice or less per week. Functional constipation accounts for 3% of general pediatric visits and up to 25% of pediatric gastroenterology visits. Constipation and fecal impaction can lead ...
What is the current status of trial NCT01823848?
This trial is currently terminated. It is a NA study. The enrollment target is 40 participants. The study started on 2013-04. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01823848?
The interventions under investigation include: Sodium phosphate enema (DRUG), Normal saline enema (DRUG), Mineral oil enema (DRUG).
Who is sponsoring clinical trial NCT01823848?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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