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

Manish I. Shah, Department of Emergency Medicine, Stanford University School of Medicine, Palo Alto, CA, 94304, USA. mshah5@stanford.edu.
Kathleen M. Adelgais, Section of Pediatric Emergency Medicine, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA.
James M. Chamberlain, Division of Emergency Medicine, Department of Pediatrics, Children's National Hospital, The George Washington University School of Medicine and Health Sciences, Washington, D.C., USA.
Henry E. Wang, Department of Emergency Medicine, The Ohio State University, Columbus, OH, USA.
Lindsey A. Morgan, Division of Pediatric Neurology, Department of Neurology, University of Washington, Seattle, WA, USA.
James J. Riviello, Division of Neurology, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.
Rana R. Said, Division of Neurology, Department of Pediatrics, University of Texas Southwestern, Dallas, TX, USA.
Joseph E. Sullivan, Department of Neurology & Pediatrics, University of California San Francisco, San Francisco, CA, USA.
Kimia F. Ghaffari, Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.
Kathryn M. Kothari, Division of Emergency Medicine, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.
Mohsen Saidinejad, Department of Emergency Medicine, Harbor - University of California Los Angeles Medical Center, Torrance, CA, USA.
Robert A. Lowe, Columbus Division of Fire, Columbus, OH, USA.
Raymond L. Fowler, Division of Emergency Medical Services, Department of Emergency Medicine, University of Texas Southwestern, Dallas, TX, USA.
Catherine R. Counts, Section of Emergency Medical Services, Department of Emergency Medicine, University of Washington, Seattle, WA, USA.
Claudia R. Morris, Division of Emergency Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Emory University, Atlanta, GA, USA.
Jonathan R. Studnek, Wake County Emergency Medical Services, Raleigh, NC, USA.
Nancy K. Glober, Department of Emergency Medicine and Indianapolis Emergency Medical Services, University of Indiana, Indianapolis, IN, USA.
Caleb E. Ward, Division of Emergency Medicine, Department of Pediatrics, Children's National Hospital, The George Washington University School of Medicine and Health Sciences, Washington, D.C., USA.
Brian M. Clemency, Department of Emergency Medicine, University at Buffalo, Buffalo, NY, USA.
Nicholas Patrick, Department of Emergency Medicine, Oregon Health and Sciences University, Portland, OR, USA.
Rachel D. Munn, Department of Emergency Medicine, University of Arizona, Tucson, AZ, USA.
Graham M. Brant-Zawadzki, Department of Emergency Medicine, University of Utah, Salt Lake City, UT, USA.
Christian Martin-Gill, Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Daniel K. Nishijima, Department of Emergency Medicine, University of California Davis, Sacramento, CA, USA.
Kevin Li, Department of Emergency Medicine, University of California San Francisco, San Francisco, CA, USA.
Neomi Sepulveda, Department of Emergency Medicine, McGovern Medical School at the University of Texas Health Sciences Center, Houston, TX, USA.
John M. VanBuren, Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.

Document Type

Journal Article

Publication Date

12-13-2025

Journal

Trials

DOI

10.1186/s13063-025-09342-3

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 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.

Department

Pediatrics

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