Low-dose Propofol for Pediatric Migraine
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Propofol; Standard Treatment
Intervention type(s): Drug; Drug
Intervention description(s): Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses; Ketorolac, Diphenhydramine and Metoclopramide
Other intervention name(s): Diprivan; NSAIDs / Dopamine Antagonists
Intervention MeSH terms: Dopamine; Propofol; Dopamine Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine Headache; Pediatric