Methodology for the Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study
Abstract
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…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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