Seizure – Pediatric Dose Optimization for Seizures in Emergency Medical Services
What is the goal of this study?
The PediDOSE study is designed to evaluate if a standardized method for paramedics to administer seizure medication leads to timely delivery of the right dose.
Who can join the study?
This study might be a good fit for:
- Children ages 6 month to 13 years who are treated by emergency medical services for seizures.
What will happen if my child takes part in this study?
The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) study is an emergency medicine study designed to evaluate if a standardized method for paramedics to administer seizure medication leads to timely delivery of the right dose. The purpose of this study is to simplify how paramedics give medication to seizing children to stop the seizure and to decrease the number of children still seizing when they arrive at a hospital emergency department. By replacing complicated dose calculations with age-based standardized dosing, we aim to increase the number of children who receive the right amount of seizure-stopping treatment before arriving at the hospital.
Midazolam is the benzodiazepine medication that will be used in this study. This medication is the standard of care for treating seizures. Like all medications, midazolam has risks. In this study, we will determine if the risks increase or decrease when using the age-based standardized dosing. We will look specifically at how breathing is affected, since respiratory depression (decreased breathing rate) is a known risk of midazolam. On the other hand, a potential benefit of this study is that more children may receive the right treatment to stop their seizures early.
Paramedics will transport children enrolled in the study to an emergency department because of a seizure. The emergency medical services agency will share transport records with the research team, and we will use data from that transport record and hospital visit to determine whether or not the children enrolled in this study received medication and if their seizure stopped.
Participating emergency medical services agencies will be randomly assigned a timeline for adopting the standardized treatment plan over the course of the four-year study. This will allow researchers to compare the new standardized treatment plan to current methods and allow for the new method to be safely implemented for children who need emergency treatment for seizures.
Treatment methods for seizures are prescribed by a doctor who oversees all medical care for the entire agency, and changes to the medical treatment method will be adopted by all paramedics who are working for the emergency medical services agency. Therefore, no alternative treatments for seizure will be available and there is no way to opt-out of the study. However, parents of children enrolled in this study will be able to request that no further data be collected for research.
Because treating a seizure must be done emergently and ideally within five minutes, there will not be time to ask parents for permission to enroll their child in the study. Parents will be notified in person, by phone, or by mail after their child is enrolled so that they can tell us if they object to further participation.
For more information visit texaschildrens.org/pedidose.
If you would like to take a survey to provide feedback on the study visit:
Who can I contact for more information?
To learn more, call (206) 987-2939 or email firstname.lastname@example.org.