drugset / Trial / NCT02485418

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

NCT02485418 ↗

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2015-06
Primary completion
2023-01-24
Completion
2023-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 40 ug/kg Intravenous

Indications