Low-dose Propofol for Pediatric Migraine

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Migraine Headache
Drug: Propofol
Drug: Standard Treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Reduction in Self-Assessed Pain [ Time Frame: 15 minutes after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 160
Study Start Date: November 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Therapy
Ketorolac, Diphenhydramine, and Metoclopramide
Drug: Standard Treatment
Ketorolac, Diphenhydramine and Metoclopramide
Experimental: Experimental Treatment Group
Subanesthetic dose propfol
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

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604785

Contacts
Contact: Garth D Meckler, MD, MSHS 503-494-7500 mecklerg@ohsu.edu
Contact: David Spiro, MD, MPH 503-494-7500 spirod@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Garth D Meckler, MD, MSHS    503-494-7500    mecklerg@ohsu.edu   
Sub-Investigator: David Sheridan, MD         
Sub-Investigator: Thomas Koch, MD         
Sub-Investigator: David Spiro, MD, MPH         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Garth D Meckler, MD, MSHS Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Garth Meckler, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01604785     History of Changes
Other Study ID Numbers: Meckler01
Study First Received: May 22, 2012
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Migraine Headache
Pediatric

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 24, 2014