Improving Seizure Treatment for Children in Ambulances

This study, called PediDOSE, aims to improve how paramedics treat seizures in children on ambulances. Currently, many children still have seizures when they arrive at the emergency room. This might be because the medicine, midazolam, is not given in the right dose or quickly enough. This study compares two ways paramedics give midazolam: a new, standardized protocol using only intramuscular (IM) or intranasal (IN) midazolam with age-based doses, versus the usual protocol that varies by ambulance agency. The study will look at whether children are still seizing when they arrive at the emergency department. Children aged 6 months to 13 years who are actively seizing, under paramedic care, and transported by a participating ambulance agency can join, unless they have a benzodiazepine allergy, are pregnant, or have severe growth restriction.

Study design
This interventional study plans to include 6,700 participants. It compares a standardized seizure protocol with a conventional seizure protocol.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, seizing on emergency department arrival, is measured between arrival and 10 minutes after arrival.

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NCT05121324

Pediatric Dose Optimization for Seizures in Emergency Medical Services

Recruiting
PHASE3Ages 6–13InterventionalTreatment
Stanford University
~6,700 participants
Updated 2025-09-30 on ClinicalTrials.gov
What's tested:Standardized seizure protocolConventional seizure protocol

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Seizing on emergency department arrival
Measured over Between arrival to the emergency department and 10 minutes after arrival
Seizures
20 sites across 16 states
California3
Ohio2
Texas2
Arizona1
Colorado1
District of Columbia1
Georgia1
Indiana1
  • Manish I Shah, MD, MS · PRINCIPAL_INVESTIGATOR · Stanford University

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Eligibility criteria

Inclusion

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

Exclusion

A prior history of a benzodiazepine allergy; OR
Known or presumed pregnancy; OR
Severe growth restriction based on the paramedic's subjective assessment
  • Seizing on emergency department arrivalBetween arrival to the emergency department and 10 minutes after arrival

    Binary assessment of whether the participant is seizing or not upon arrival to the emergency department, as measured by either a rapid response electroencephalogram (preferred) or clinical judgement (alternative).