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NCT01604785 · ClinicalTrials.gov registry record · Phase 2
Low-dose Propofol for Pediatric Migraine
A Phase 2 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT01604785 is a Phase 2 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 74 participants.
The verdict
NCT01604785, a Phase 2 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
Propofol, a general anesthetic, has been suggested to be effective for the treatment of migraine headaches in adults when used in subanesthetic doses (lower doses than those used for anesthesia or sedation). Initial retrospective review of the investigators experience with propofol for migraine in children suggests that it is safe and may be more effective than standard treatments used in the emergency department. The investigators retrospective series had a small subject population and a larger study is needed to compare propofol to current available treatments. Standard treatment currently consists of a "cocktail" of medications that include anti-nausea medicines (metoclopramide and diphenhydramine) and an analgesic (ketorolac) as well as intravenous fluids. Subjects assigned to the experimental group (Propofol) will receive the same intravenous fluids and up to five doses of propofol. All subjects will undergo assessment of their pain (self-rated on a scale from 0-10) before and after treatment. Post-visit clinical data will be collected from the subject's medical record and subjects will be called by telephone 24-48 hours after discharge from the emergency department to ask how they are doing and whether they required any additional treatments such as home medications or by other medical professionals other than OHSU.
Interventions
- DRUG Propofol
- DRUG Standard Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2012-11 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01604785
The ClinicalTrials.gov registry entry for NCT01604785 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Propofol is the first listed.
NCT01604785 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01604785 about?
NCT01604785 is a clinical study titled "Low-dose Propofol for Pediatric Migraine". Propofol, a general anesthetic, has been suggested to be effective for the treatment of migraine headaches in adults when used in subanesthetic doses (lower doses than those used for anesthesia or sedation). Initial retrospective review of the investigators experience with propofol for migraine in c...
What is the current status of trial NCT01604785?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2012-11. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01604785?
The interventions under investigation include: Propofol (DRUG), Standard Treatment (DRUG).
Who is sponsoring clinical trial NCT01604785?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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