Low-dose Propofol for Pediatric Migraine
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Headache
Intervention: Propofol (Drug); Standard Treatment (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s): Garth D Meckler, MD, MSHS, Principal Investigator, Affiliation: Oregon Health and Science University
Overall contact: Garth D Meckler, MD, MSHS, Phone: 503-494-7500, Email: mecklerg@ohsu.edu
Summary
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Reduction in Self-Assessed Pain
Secondary outcome: Safety
Eligibility
Minimum age: 7 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Garth D Meckler, MD, MSHS, Phone: 503-494-7500, Email: mecklerg@ohsu.edu
Oregon Health & Science University, Portland, Oregon 97239, United States; Not yet recruiting Garth D Meckler, MD, MSHS, Phone: 503-494-7500, Email: mecklerg@ohsu.edu David Sheridan, MD, Sub-Investigator Thomas Koch, MD, Sub-Investigator David Spiro, MD, MPH, Sub-Investigator
Additional Information
Starting date: November 2012
Last updated: October 12, 2012
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