Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients (Propofol2014)

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 Overview

• Status: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Drug: Propofol

Detailed Description

The aim of this prospective study is to evaluate the efficacy and safety of propofol administration in a hospital setting, as an abortive medication for children aged 7-18 with migraines.

Primary outcome:

Based on the adult and the limited pediatric data available we hypothesize that propofol infusion in sub anesthetic dose, will result in either complete resolution or improve the headache pain scores by 50% from the baseline pain scores. Patients will be assessed with a 0-10 Numeric Pain Rating Scale.

Secondary outcomes:

• Time to beginning of effect (from the beginning of the propofol infusion till first improvement in pain score noted)
• Duration of effect (from the end of propofol administration till discharge criteria are meet or if treatment is ineffective, till start of new therapy)
• Total propofol dose based on weight.

Prior to initiation of DHE infusion, the subjects will receive sub-anesthetic doses of propofol infusion:

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. The propofol infusion will be terminated if:

• The patient has no pain, or greater than 50% reduction in pain scores as compared to the pretreatment pain score
• After completing 40 minutes of propofol infusion at 40 mcg/kg/min irrespective of the pain score
• If the anesthesiologist feels cardio-pulmonary depression, airway obstruction or over sedation (Ramsay Sedation Score greater than 3)has occurred

If the propofol infusion is effective in resolving headache symptoms, then subjects will be monitored for at least 30 minutes after termination of infusion. Outpatient subjects would then be discharged home; inpatient subjects would resume standard care treatment.

If propofol infusion is not successful in resolving headache, then the subjects will proceed with DHE infusion per standard of care. If the subject still has no relief, the study investigators will discuss further options with the subject and parents, including hospital admission for further therapy for outpatient subjects.

For all subjects who receive propofol infusion, follow-up will occur at 24 and 48 hours via phone call to evaluate headache status and recover information on headache symptoms and side effects.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deryk Walsh, MD; Phone Number: 214-456-6393; Email: deryk.walsh@childrens.com
• Study Contact Backup: Name: Jordan Schutt; Phone Number: 214-456-8981; Email: jordan.schutt@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Health Children's Medical Center Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Headache Pain Score	Change in pain score on 0-10 Numeric Pain Rating Scale with 0 being no pain and 10 being severe pain. Subjects assessed at 10 minute intervals for the duration of the infusion with reporting of change from baseline to 60 minutes	Duration of propofol infusion (between 5 and 60 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NPRS Pain Scores at 24 and 48 Hours Post Infusion	For subjects who experience a change in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain.	Assessments of NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain at 24 and 48 hours after discharge from infusion
Total Propofol Dose	Total dose of propofol administered (mg/kg)	60 minutes

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Deryk Walsh, MD, Children's Medical Center Dallas

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): January 24, 2023
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimated): June 30, 2015

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: STU 042014-002