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Low-dose Propofol for Pediatric Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Garth Meckler, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01604785
First received: May 22, 2012
Last updated: August 16, 2016
Last verified: August 2016
  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
Official Title: Low-dose Propofol for Abortive Therapy of Pediatric Migraine in the Emergency Department

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


Enrollment: 74
Study Start Date: November 2012
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Treatment Group
Propofol at subanesthetic dose via IV push
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
Active Comparator: Standard Treatment Group
Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion
Drug: Standard Treatment
Ketorolac, Diphenhydramine and Metoclopramide
Other Name: NSAIDs / Dopamine Antagonists

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
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

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Garth D Meckler, MD, MSHS Oregon Health and Science University
Study Director: David Sheridan, MD sheridda@ohsu.edu
  More Information

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: August 16, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Propofol
Diphenhydramine
Dopamine Antagonists
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016