Pediatric Dose Optimization for Seizures in Emergency Medical Services
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
Interventions
Standardized seizure protocol
Conventional seizure protocol
Conditions
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