Pediatric Dose Optimization for Seizures in Emergency Medical Services
- Conditions
- Seizures
- Interventions
- Drug: Standardized seizure protocolDrug: Conventional seizure protocol
- Registration Number
- NCT05121324
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6000
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Standardized seizure protocol This arm will be exposed to the study intervention: a standardized seizure protocol. Control Conventional seizure protocol This arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm
- Primary Outcome Measures
Name Time Method Seizing on emergency department arrival Between arrival to the emergency department and 10 minutes after arrival Binary assessment of whether the participant is seizing or not upon arrival to the emergency department, as measured by either a rapid response electroencephalogram (preferred) or clinical judgement (alternative).
- Secondary Outcome Measures
Name Time Method Respiratory failure Between paramedic arrival on scene until 30 minutes after emergency department arrival A binary assessment of insufficient breathing at any point during EMS care or within 30 minutes of emergency department arrival, defined as having received bag valve mask ventilation, bi-level positive airway pressure, placement of a supraglottic airway or endotracheal intubation.
Time to first midazolam administration From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last Time in minutes from paramedic arrival to the scene until the paramedic administers midazolam to the patient
Trial Locations
- Locations (20)
Emory University
🇺🇸Atlanta, Georgia, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Children's National Hospital
🇺🇸Washington, District of Columbia, 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
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of California, Davis
🇺🇸Sacramento, California, United States