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NCT01549002 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children
A Phase 3 study of Pain and Abscess, sponsored by Columbia University.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01549002 is a Phase 3 study of Pain and Abscess that has completed, run by Columbia University. The registered enrollment target is 20 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01549002, a Phase 3 study of Pain and Abscess, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Children can develop abscesses (a collection of pus under their skin) that require a physician to cut it open to let the pus drain out. This is a painful procedure. Most medical professionals will use numbing cream and inject numbing medicine into the skin, just like at the dentist, to help reduce the pain. While this helps minimize the pain of cutting the skin, it doesn't help the pain associated with draining out the pus. There are many strategies and medications available to physicians to help decrease the pain of this procedure. Most of the medications available to treat the pain require the placement of an intravenous (IV) catheter through the patient's skin, which itself is a painful procedure. In the investigators emergency department, many patients with abscesses that need a procedure to drain the pus receive a medicine called morphine through an IV. Some pain medicines, however, can be sprayed into a patient's nose, and have been shown to be helpful at reducing the pain of a broken bone or a burn. These medicines do not require the placement of an IV. The purpose of this research study is to determine whether a medicine called fentanyl, when sprayed into the nose of patients aged 4 to 18 years undergoing abscess drainage, is not worse than IV morphine in decreasing the pain of the procedure. After the risks and benefits of the study are explained to patients and their parents, written informed consent will be obtained. Written informed assent will be obtained for patients older than 8 years of age. Like the flipping of a coin, a computer program will decide randomly which half of the patients will receive fentanyl nose spray and which half will receive morphine by IV. The patients assigned to receive fentanyl nose spray will not have an IV placed. The patients assigned to receive morphine will have an IV placed. Both groups of patients will have the abscess drainage procedure done the same way. All patients will be videotaped in order to score their pa
Interventions
- DRUG Intranasal Fentanyl
- DRUG Intravenous Morphine
Study Locations (1)
New York
- Alexandra & Steven Cohen Children's Emergency Department of Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01549002
The ClinicalTrials.gov registry entry for NCT01549002 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (93% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Intranasal Fentanyl is the first listed.
NCT01549002 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01549002 about?
NCT01549002 is a clinical study titled "Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children". Children can develop abscesses (a collection of pus under their skin) that require a physician to cut it open to let the pus drain out. This is a painful procedure. Most medical professionals will use numbing cream and inject numbing medicine into the skin, just like at the dentist, to help reduce t...
What is the current status of trial NCT01549002?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2012-01. Estimated completion is 2013-04.
What conditions does trial NCT01549002 study?
This clinical trial studies the following conditions: Pain, Abscess.
What interventions are being tested in trial NCT01549002?
The interventions under investigation include: Intranasal Fentanyl (DRUG), Intravenous Morphine (DRUG).
Who is sponsoring clinical trial NCT01549002?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01549002 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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