Low-dose Propofol for Pediatric Migraine
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 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.
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