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

Study Overview
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Brief Summary
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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: Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches Evaluate effective and safe dosing limits in pediatric populations Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent Endpoints for the study will be: Number of enrolled patients 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.

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

Conditions
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Migraine Headache

Intervention / Treatment
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* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol infusion<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia | 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. | 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. | 
| Total propofol dose | Total dose of propofol administered (mg/kg) | 60 minutes |