RecruitingPhase 3NCT05121324

Pediatric Dose Optimization for Seizures in Emergency Medical Services

Pediatric Dose Optimization for Seizures in EMS (PediDOSE)


Sponsor

Stanford University

Enrollment

6,700 participants

Start Date

Aug 8, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 MonthsMax Age: 13 Years

Inclusion Criteria3

  • 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 Criteria3

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

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Interventions

DRUGStandardized 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).

DRUGConventional 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).


Locations(20)

University of Arizona

Tucson, Arizona, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Children's National Hospital

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

Emory University

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

University at Buffalo

Buffalo, New York, United States

Mecklenburg EMS

Charlotte, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Oregon Health and Sciences University

Portland, Oregon, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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