Low-dose propofol infusion as an abortive treatment for migraine headaches in pediatric patients

Study ID: STU 042014-002

Summary

Goals of the study are to evaluate: 1.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 For all subjects, propofol will be delivered through an infusion pump starting at a rate of 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. Propofol infusion will be terminated if: -Pain score decreases to 0-2 for 10 minutes, and patient is satisfied with result -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 Patients will be monitored for at least 30 minutes following discontinuation of infusion.

Participant Eligibility

Inclusion Criteria * Patients with a diagnosis of migraine headache per ICHD x 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. * Patients age 7-18 years old * Gender: both male and female * Appropriate fasting interval as per ASA guidelines * Children presenting to the Headache Clinic in the Pain Management Clinic for treatment of migraine headache or who have been admitted to the hospital for treatment of migraine headache. * Patients will be recruited from the investigator[Single Quote]s patients in the headache clinic or from inpatient consults to the pain service

Cancer Related: No
Healthy Volunteers: No
UT Southwestern Principal Investigator: DERYK LEE WALSH

Contact:

Kiley Poppino

Kiley.Poppino@UTSouthwestern.edu