Methodology for the Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study.

BACKGROUND: Seizures are one of the most common reasons for emergency medical services (EMS) activation for children, and current EMS practice results in underdosing and delayed delivery of anti-seizure medication. A prehospital evidence-based guideline recommends using intranasal or intramuscular midazolam as first-line treatment for pediatric seizures. Despite attempts to implement these guidelines, one-third of children having a paramedic-witnessed seizure have ongoing seizures on emergency department (ED) arrival; this may be due to inadequate or delayed midazolam dosing. Replacing the error-prone, sequential calculations with age-based midazolam dosing may be simpler, faster, and more effective without compromising safety. The objective of this manuscript is to describe the methodology of the Pediatric Dose Optimization for Seizures in EMS (PediDOSE) study, a clinical trial designed to compare the effectiveness and safety of an EMS protocol with four age-based categories for midazolam dosing relative to the current weight-based dosing.

METHODS: We are conducting a large EMS-based stepped wedge trial in the Pediatric Emergency Care Applied Research Network (PECARN) by implementing midazolam dosing based on four age categories in seizure protocols in EMS systems in 20 cities. We believe that this implementation will stop more seizures before ED arrival without increasing respiratory failure rates. The primary aim of this study is to compare the effectiveness of age-based EMS midazolam dosing compared to the current weight-based dosing on seizure cessation upon ED arrival. The secondary aim is to determine the frequency of respiratory failure in children after the implementation of EMS midazolam dosing based on these age categories.

CONCLUSION: If this study demonstrates that an EMS patient care protocol with age-based midazolam dosing is safe and more effective than current practice, the potential impact of this study is a paradigm shift in the treatment of pediatric seizures that can be easily implemented in EMS systems across the country. Beyond seizures, the concept of age-based dosing may also be applicable to other commonly encountered pediatric prehospital conditions for which medication may be indicated.