Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients

Overview

Propofol has been used in adult populations to treat migraines as an abortive agent. Investigators plan to investigate its efficacy as an abortive agent in the pediatric population when administered as a safe low-dose infusion. Goals of the study are to:

1. Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches

2. Evaluate effective and safe dosing limits in pediatric populations

3. Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent

Endpoints for the study will be:

1. Number of enrolled patients

2. Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under the guidance and supervision of a board certified pediatric anesthesiologist with the appropriate monitoring equipment and readily available emergency equipment. Investigators hope to demonstrate more rapid improvement and decreased side-effect as compared to standard care.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Interventions

  • Drug: Propofol
    • Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.

Arms, Groups and Cohorts

  • Experimental: Propofol infusion
    • All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule: 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in Headache Pain Score
    • Time Frame: Duration of propofol infusion (between 5 and 60 minutes)
    • Reduction in pain score on 0-10 Numeric Pain Rating Scale. Subjects assessed at 5 minute intervals for the duration of the infusion

Secondary Measures

  • Duration of analgesia
    • Time Frame: Assessments at 10 minute intervals from the start of infusion while on site, and at 24 and 48 hours after discharge, up to 72 hours.
    • For subjects who experience improvement in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores.
  • Total propofol dose
    • Time Frame: 60 minutes
    • Total dose of propofol administered (mg/kg)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with a diagnosis of migraine headache per ICHD – 3 (International Classification of Headache Disorders)
  • The subjects will have a history of migraine headaches with a presentation consistent with presentations of their headaches in the past with no indication for further investigation for secondary causes of his/her headache
  • Documented pain score greater than or equal to 6 on a 0-10 Numeric Pain Rating Scale
  • Current migraine has a greater than 24 hours duration with a current pain score of 6 or greater on a 0-10 Numeric Pain Rating Scale
  • Subjects will be scheduled for DHE infusion therapy for treatment of migraines per standard medical care
  • Patients age 7-18 years old
  • Gender: both male and female
  • Appropriate fasting interval as per ASA guidelines

Exclusion Criteria

  • No long acting triptan therapy within 24 hours
  • No shorter acting triptan therapy within 6 hours
  • No ergot alkaloid derivatives within the last 24 hours
  • No opioid within 2 hours
  • No NSAID or acetaminophen within 1 hour of infusion
  • Use of sedative medications within 6 hours of infusion, including opioids, benzodiazepines, barbiturates
  • Headache not consistent with subject's headache history needing further work-up
  • Headache duration less than 24 hours
  • Subjects in which an intravenous line could not be secured
  • Subjects with history of significant reflux or hiatal hernia
  • Subjects with history of significant cardio pulmonary disorders
  • Patient not fasting as per ASA guidelines

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Deryk Walsh, MD, 214-456-6393, deryk.walsh@childrens.com

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