Seizures are one of the most common reasons why people call 9-1-1 for children. Seizures that do not stop on their own can be life-threatening. Paramedics are Emergency Medical Services (EMS) clinicians who are trained to treat seizures with a benzodiazepine medication called midazolam. Midazolam is a proven treatment paramedics already use to stop a seizure quickly. But delays in administering midazolam occur when paramedics must do multi-step calculations to determine the dose or try to obtain intravenous access on a child. Unfortunately, approximately 1/2 of children receive the wrong dose, usually an underdose. Delayed and underdosed medication result in 1/3 of these children arriving via ambulance to the emergency department (ED) still seizing. 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. Principal Investigator, Manish I. Shah, MD, MS designed PediDOSE, which specifically aims to decrease the number of children arriving at the ED with an ongoing seizure while maintaining patient safety.
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, who Indianapolis Emergency Medical Services (IEMS) transports to IU Health Riley Hospital for Children for active seizures. It is exciting that the Indianapolis community is one of 20 locations across the country that will enroll patients over a 4-year period. 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 to 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.
We invite you to learn more about the study by visiting our website www.texaschildrens.org/pedidose-study where you can read more about the study procedures and provide your feedback about EFIC.