Pediatric Dose Optimization for Seizures in Emergency Medical Services

Официальное название

Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

Обзор

The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children. PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner. One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice. Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings. If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.

Вмешательства

• Препарат Standardized seizure protocol
  The intervention is a standardized seizure protocol for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg).
• Препарат Conventional seizure protocol
  The control is the EMS agency's current seizure protocol, based on conventional calculation-based dosing. These vary from one EMS agency to the other with respect to recommended midazolam doses ranging from 0.05-0.3 mg/kg and with multiple route choices listed, including intravenous, intraosseous, intramuscular, intranasal, and rectal. for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosin

Первичные конечные точки

• Seizing on emergency department arrival [Срок оценки: Between arrival to the emergency department and 10 minutes after arrival]

Вторичные конечные точки (2)

• Respiratory failure [Срок оценки: Between paramedic arrival on scene until 30 minutes after emergency department arrival]
• Time to first midazolam administration [Срок оценки: From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last]

Критерии участия

Критерии включения

• Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND
• Under the care of a paramedic; AND
• Transported by an EMS agency participating in the study

Критерии исключения

• A prior history of a benzodiazepine allergy; OR
• Known or presumed pregnancy; OR
• Severe growth restriction based on the paramedic's subjective assessment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 20 центров

• University of Arizona — Tucson
• Children's Hospital of Los Angeles — Los Angeles
• University of California, Davis — Sacramento
• University of California, San Francisco — San Francisco
• University of Colorado — Aurora
• Children's National Hospital — Washington D.C.
• Emory University — Atlanta
• Indiana University — Indianapolis
• … и ещё 12 центров

Публикации

• Shah MI, Ostermayer DG, Browne LR, Studnek JR, Carey JM, Stanford C, Fumo N, Lerner EB. Multicenter Evaluation of Prehospital Seizure Management in Children. Prehosp Emerg Care. 2021 Jul-Aug;25(4):475-486. doi: 10.1080/10903127.2020.1788194. Epub 2020 Jul 17. PMID 32589502
• Carey JM, Studnek JR, Browne LR, Ostermayer DG, Grawey T, Schroter S, Lerner EB, Shah MI. Paramedic-Identified Enablers of and Barriers to Pediatric Seizure Management: A Multicenter, Qualitative Study. Prehosp Emerg Care. 2019 Nov-Dec;23(6):870-881. doi: 10.1080/10903127.2019.1595234. Epub 2019 May 13. PMID 30917730
• Shah MI, Macias CG, Dayan PS, Weik TS, Brown KM, Fuchs SM, Fallat ME, Wright JL, Lang ES. An Evidence-based Guideline for Pediatric Prehospital Seizure Management Using GRADE Methodology. Prehosp Emerg Care. 2014;18 Suppl 1:15-24. doi: 10.3109/10903127.2013.844874. Epub 2013 Dec 3. PMID 24298939
• Johnson AR, Riches NO, VanBuren JM, Corona AE, Jacobsen K, Yang S, Shah MI; Pediatric Emergency Care Applied Research Network (PECARN) PediDOSE Study Investigators. Measuring the efficacy of community consultation in a pediatric exception from informed consent trial. Acad Emerg Med. 2025 May;32(5):506-515. doi: 10.1111/acem.15073. Epub 2024 Dec 29. PMID 40365924
• Kornblith AE, Singh C, Innes JC, Chang TP, Adelgais KM, Holsti M, Kim J, McClain B, Nishijima DK, Rodgers S, Shah MI, Simon HK, VanBuren JM, Ward CE, Counts CR. Analyzing patient perspectives with large language models: a cross-sectional study of sentiment and thematic classification on exception from informed consent. Sci Rep. 2025 Feb 20;15(1):6179. doi: 10.1038/s41598-025-89996-w. PMID 39979559
• Ward CE, Adelgais KM, Holsti M, Jacobsen KK, Simon HK, Morris CR, Gonzalez VM, Lerner G, Ghaffari K, VanBuren JM, Lerner EB, Shah MI; Pediatric Emergency Care Applied Research Network (PECARN) PediDOSE Study Group. Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial. Acad Emerg Med. 2024 J PMID 38450918

Идентификаторы

NCT: NCT05121324 · 73018 · U01NS114042 · BCM H-49824

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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