Low-dose Propofol for Pediatric Migraine
Completed · Phase 2/Phase 3
Conditions studied: Migraine Headache
In brief
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.
Key facts
- Study ID
- NCT01604785
- Run by
- Oregon Health and Science University
- People needed
- 74
- Starts
- 2012-11-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2018-12-31
Who can join
Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children 7-18 years of age
- Acute Migraine Headache
You may not qualify if…
- Head Trauma
- CNS infection
- CNS tumor
- Previous CNS surgery or device
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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