Low-dose Propofol for Pediatric Migraine

This study is not yet open for participant recruitment.
Verified October 2012 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Garth Meckler, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01604785
First received: May 22, 2012
Last updated: October 12, 2012
Last verified: October 2012

May 22, 2012
October 12, 2012
November 2012
November 2015   (final data collection date for primary outcome measure)
Reduction in Self-Assessed Pain [ Time Frame: 15 minutes after administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01604785 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Continuous every 5 minutes ] [ Designated as safety issue: Yes ]
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
Not Provided

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Migraine Headache
  • Drug: Propofol
    Sub-anesthetic dose propofol: 0.5 mg/kg IV push to maximum dose of 30mg q15 minutes to a maximum of 5 doses
  • Drug: Standard Treatment
    Ketorolac, Diphenhydramine and Metoclopramide
  • Active Comparator: Standard Therapy
    Ketorolac, Diphenhydramine, and Metoclopramide
    Intervention: Drug: Standard Treatment
  • Experimental: Experimental Treatment Group
    Subanesthetic dose propfol
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
January 2016
November 2015   (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
Both
7 Years to 18 Years
No
Contact: Garth D Meckler, MD, MSHS 503-494-7500 mecklerg@ohsu.edu
Contact: David Spiro, MD, MPH 503-494-7500 spirod@ohsu.edu
United States
 
NCT01604785
Meckler01
Yes
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
Oregon Health and Science University
October 2012

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