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NCT05121324PHASE3Recruiting

Pediatric Dose Optimization for Seizures in Emergency Medical Services

Stanford University

Start Date

8/8/2022

Completion Date

9/30/2026

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.

Eligibility Criteria

Age Range: No minimum to 13 years

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

Interventions

DRUG

Standardized seizure protocol

DRUG

Conventional seizure protocol

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Conditions

Seizures

Locations

University of Arizona

Tucson, Arizona 85724

United States

Children's Hospital of Los Angeles

Los Angeles, California 90027

United States

University of California, Davis

Sacramento, California 95817

United States

University of California, San Francisco

San Francisco, California 94143

United States

University of Colorado

Aurora, Colorado 80045

United States

Children's National Hospital

Washington D.C., District of Columbia 20010

United States

Emory University

Atlanta, Georgia 30322

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Michigan

Ann Arbor, Michigan 48105

United States

University at Buffalo

Buffalo, New York 14203

United States

Mecklenburg EMS

Charlotte, North Carolina 28226

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Oregon Health and Sciences University

Portland, Oregon 97239

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States

University of Texas Southwestern

Dallas, Texas 75235

United States

Baylor College of Medicine

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84108

United States

University of Washington

Seattle, Washington 98104

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States