Low-dose Propofol for Pediatric Migraine

There has been little advancement in abortive migraine therapies in recent decades, and few
proven treatments exist for acute migraine, particularly in children. 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.

All subjects presenting to the pediatric emergency department with signs/symptoms of migraine
headache will be screened for the study. Subjects who are eligible will be provided
information about the study and consent/assent forms from a member of the research team, and
asked whether they are interested in participating.

All study subjects will receive acetaminophen (Tylenol) or ibuprofen (Motrin) for their
headache if they have not already tried these first-line treatments at home; those with
persistent symptoms requiring further treatment who consent to participate in the study will
be randomized to receive either standard treatment or propofol. 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. During treatment they will have close
monitoring of their vital signs. No additional laboratory tests or procedures are involved.
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.

The study data will be presented in summary tables that outline subjects' clinical
presentation prior to treatments, and response to study drug during their visit. The main
variables of interest include effectiveness (determined as a reduction in self-reported pain
score), length of stay in the pediatric emergency department, recurrent headache requiring
emergency treatment within 24 hours and whether any adverse effects occur. These will be
compared between the 2 study groups with basic statistics.

Inclusion Criteria:

- Children 7-18 years of age

- Acute Migraine Headache

Exclusion Criteria:

- Head Trauma

- CNS infection

- CNS tumor

- Previous CNS surgery or device