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Low-dose Propofol for Pediatric Migraine

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ClinicalTrials.gov Identifier: NCT01604785
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):

May 22, 2012
May 24, 2012
August 18, 2016
November 2012
August 2016   (Final data collection date for primary outcome measure)
Reduction in Self-Assessed Pain [ Time Frame: 15 minutes after administration ]
Same as current
Complete list of historical versions of study NCT01604785 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Continuous every 5 minutes ]
Monitoring of all patient vital signs including HR, BP, POX, RR and mental status
Same as current
Not Provided
Not Provided
Low-dose Propofol for Pediatric Migraine
Low-dose Propofol for Abortive Therapy of Pediatric Migraine in the Emergency Department

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.

Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Migraine Headache
  • Drug: Propofol
    Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses
    Other Name: Diprivan
  • Drug: Standard Treatment
    Ketorolac, Diphenhydramine and Metoclopramide
    Other Name: NSAIDs / Dopamine Antagonists
  • Experimental: Experimental Treatment Group
    Propofol at subanesthetic dose via IV push
    Intervention: Drug: Propofol
  • Active Comparator: Standard Treatment Group
    Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion
    Intervention: Drug: Standard Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children 7-18 years of age
  • Acute Migraine Headache

Exclusion Criteria:

  • Head Trauma
  • CNS infection
  • CNS tumor
  • Previous CNS surgery or device
Sexes Eligible for Study: All
7 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Garth Meckler, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Garth D Meckler, MD, MSHS Oregon Health and Science University
Study Director: David Sheridan, MD sheridda@ohsu.edu
Oregon Health and Science University
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP