Low-dose Propofol for Pediatric Migraine

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Diphenhydramine; Dopamine; Dopamine Antagonists; Propofol

Criteria

Inclusion Criteria:

• Children 7-18 years of age

• Acute Migraine Headache

Exclusion Criteria:

• Head Trauma

• CNS infection

• CNS tumor

• Previous CNS surgery or device