Oregon Health & Science University researchers are joining a nationwide study working to identify the most effective dose of a medication that provides life-saving treatment for seizures in children.
Seizures are one of the most common reasons that people call 9-1-1 for children — and can be life-threatening if they don’t stop on their own or are stopped by medication. A common treatment used by paramedics, midazolam, has proved effective in quickly stopping a seizure. However, delays in administering midazolam can occur when paramedics must perform multi-step calculations to determine the dose or administer the drug intravenously to a child. As a result, approximately half of children treated receive the wrong dose, usually an insufficient dose.
“When paramedics are in the heat of the moment trying to stabilize a seizing child, they don’t have time to do complex calculations to determine the dose,” says Matt Hansen, M.D., M.C.R., associate professor of emergency medicine in the OHSU School of Medicine, and co-director of Innovative, Disruptive, Emergency Applications for Emergency Medicine. “Children end up receiving too low of a dose, and nearly one-third of those who are underdosed are still seizing when they arrive at the emergency department. We’re excited to join this study working to improve these outcomes by equipping paramedics to quickly give the right anti-seizure medication dose.”
The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial evaluates whether an age-based, calculation-free method of quickly giving the right midazolam dose improves outcomes in children. The Portland community is one of 20 locations across the country that will enroll patients in the study over a four-year period. The PediDOSE study — designed by principal investigator Manish I. Shah, M.D., M.S., of Texas Children’s Hospital — specifically aims to decrease the number of children arriving at the emergency department with an ongoing seizure, while maintaining patient safety.
New Protocol
Emergency Medical Services, or EMS, agencies participating in this study will replace conventional methods for calculating the midazolam dose with a new, standardized treatment plan. Researchers will collect information about children ages 6 months to 13 years with active seizures who are transported by ambulance to OHSU.
The participating EMS agencies will be randomly assigned to when they will adopt the standardized treatment plan over the course of the study. This will allow researchers to compare the new standardized treatment plan with current methods and allow for safe implementation of the new standardized protocol.
A child experiencing an ongoing seizure is having a life-threatening emergency. These situations can be stressful for parents and require a paramedic’s complete focus. Therefore, it will not be practical to obtain permission from parents to have their child enrolled in the study before treatment is given. This means that eligible children will be enrolled under an accepted exception from informed consent (EFIC) process that follows federal rules for emergency research and has been approved by a research ethics review board. Parents or guardians of children enrolled in this study will be notified about the study after enrollment.
For more information about the study procedures and to provide feedback about EFIC, visit: https://redcap.utahdcc.org/redcap/surveys/?s=HPHKPDJM39