Low-dose Propofol for Pediatric Migraine

Migraine Headache Clinical Trial

Official title:

Low-dose Propofol for Abortive Therapy of Pediatric Migraine in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604785
• Other study ID #: Meckler01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2012
• Est. completion date: August 2016

Study information

• Verified date: December 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children 7-18 years of age

• Acute Migraine Headache

Exclusion Criteria:

• Head Trauma

• CNS infection

• CNS tumor

• Previous CNS surgery or device

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

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
• Standard Treatment
Ketorolac, Diphenhydramine and Metoclopramide

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-Assessed Pain	Percent pain change after initial treatment using 10 point VAS scale	15 minutes after administration
Secondary	Rebound Headache at 24 Hour Follow-up Phone Call	Percentage of subjects reporting recurrence of headache with pain greater than at time of discharge from Emergency Department	24 hours
Secondary	Emergency Department Length of Stay	Length of stay from administration of medication to Emergency Department discharge in minutes	Duration of stay in Emergency Department in Minutes