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Recruiting Phase 3 Interventional

Pediatric Dose Optimization for Seizures in Emergency Medical Services

ClinicalTrials.gov ID: NCT05121324

Public ClinicalTrials.gov record NCT05121324. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05121324
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Stanford University
Other
Enrollment
6,700 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Months to 13 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 7, 2022
Primary completion
Jul 30, 2026
Completion
Sep 29, 2026
Last update posted
Sep 29, 2025

2022 – 2026

United States locations

U.S. sites
20
U.S. states
16
U.S. cities
20
Facility City State ZIP Site status
University of Arizona Tucson Arizona 85724 Recruiting
Children's Hospital of Los Angeles Los Angeles California 90027 Recruiting
University of California, Davis Sacramento California 95817 Recruiting
University of California, San Francisco San Francisco California 94143 Recruiting
University of Colorado Aurora Colorado 80045 Recruiting
Children's National Hospital Washington D.C. District of Columbia 20010 Recruiting
Emory University Atlanta Georgia 30322 Recruiting
Indiana University Indianapolis Indiana 46202 Recruiting
University of Michigan Ann Arbor Michigan 48105 Recruiting
University at Buffalo Buffalo New York 14203 Recruiting
Mecklenburg EMS Charlotte North Carolina 28226 Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 Recruiting
Nationwide Children's Hospital Columbus Ohio 43205 Recruiting
Oregon Health and Sciences University Portland Oregon 97239 Recruiting
University of Pittsburgh Pittsburgh Pennsylvania 15224 Recruiting
University of Texas Southwestern Dallas Texas 75235 Recruiting
Baylor College of Medicine Houston Texas 77030 Recruiting
University of Utah Salt Lake City Utah 84108 Recruiting
University of Washington Seattle Washington 98104 Recruiting
Medical College of Wisconsin Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05121324, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 29, 2025 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05121324 live on ClinicalTrials.gov.

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