Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

Who is this study for? Patients with Seizures
What treatments are being studied? Seizure Protocol
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 13
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
University of Arizona
RECRUITING
Tucson
California
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
University of California, Davis
RECRUITING
Sacramento
University of California, San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Aurora
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Georgia
Emory University
RECRUITING
Atlanta
Indiana
Indiana University
RECRUITING
Indianapolis
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
Mecklenburg EMS
RECRUITING
Charlotte
New York
University at Buffalo
RECRUITING
Buffalo
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Oregon
Oregon Health and Sciences University
RECRUITING
Portland
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Texas
University of Texas Southwestern
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Washington
University of Washington
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Manish I Shah, MD, MS
mshah5@stanford.edu
650-723-3319
Backup
Leonard Basobas, MS
lbasobas@stanford.edu
773-504-5963
Time Frame
Start Date: 2022-08-08
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 6700
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: University of Utah, Baylor College of Medicine, National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov