Low-dose Propofol for Pediatric Migraine

NCT01604785 | Completed Phase 2 Results DMC

• 1 other identifier: Meckler01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Migraine Headache

Keywords

Migraine Headache; Pediatric

Outcome Measures

Primary Outcomes (1)

• Change in Self-Assessed Pain

  Percent pain change after initial treatment using 10 point VAS scale

  15 minutes after administration

Secondary Outcomes (2)

• Rebound Headache at 24 Hour Follow-up Phone Call

  24 hours

• Emergency Department Length of Stay

  Duration of stay in Emergency Department in Minutes

Study Arms (2)

Experimental Treatment Group

EXPERIMENTAL

Propofol at subanesthetic dose via IV push

Drug: Propofol

Standard Treatment Group

ACTIVE COMPARATOR

Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion

Drug: Standard Treatment

Interventions

Propofol DRUG

Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses

Also known as: Diprivan

Experimental Treatment Group

Standard Treatment DRUG

Ketorolac, Diphenhydramine and Metoclopramide

Also known as: NSAIDs / Dopamine Antagonists

Standard Treatment Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Head Trauma
• CNS infection
• CNS tumor
• Previous CNS surgery or device

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Propofol; Anti-Inflammatory Agents, Non-Steroidal; Dopamine Antagonists

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action

Results Point of Contact

• Title: David Sheridan
• Organization: Oregon Health & Science University

sheridda@ohsu.edu

503 494-8311

Study Officials

• Garth D Meckler, MD, MSHS

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• David Sheridan, MD

  sheridda@ohsu.edu

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 31, 2018
• Results First Posted: December 31, 2018

Record last verified: 2018-12

Locations

US (1)