Recruiting
Phase 3

Seizure Optimization

Sponsor:

Stanford University

Code:

NCT05121324

Conditions

Seizures

Eligibility Criteria

Sex: All

Age: 0 - 13

Healthy Volunteers: Not accepted

Interventions

Standardized seizure protocol

Conventional seizure protocol

Study Details

Brief summary:

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.

Conditions

Seizures

Study ID

NCT05121324

Start date

Aug 8, 2022

Status verified date

Sep, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 13

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

6700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

This arm will be exposed to the study intervention: a standardized seizure protocol.

active comparator: Control

This arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm

Interventions

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).

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 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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Todd P Chang, MD, MAcM

323-361-2109tochang@chla.usc.edu

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Daniel Nishijima, MD, MAS

916-734-3884dnishijima@ucdavis.edu

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Gregory W Faris, MD

317-962-3886gfaris@iu.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

University at Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Mecklenburg EMS

Recruiting

Charlotte, North Carolina, United States, 28226

Contacts

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Oregon Health and Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Matthew Hansen, MD, MCR

503-494-7551hansemat@ohsu.edu

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Sylvia Owusu-Ansah, MD, MPH

412-692-7692sylvia.owusuansah@chp.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75235

Contacts

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Andrew Latimer, MD

206-521-1588alatim@uw.edu

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

More Information

Sponsor

Stanford University

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

  • Child
  • Emergency Medical Services

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2025-09-30.