Pediatric Dose Optimization for Seizures in Emergency Medical Services
Purpose
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.
Condition
- Seizures
Eligibility
- Eligible Ages
- Between 6 Months and 13 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a stepped-wedge, cluster-randomized trial. Every 2 months, 1 of the 20 sites will transition, in a staggered manner, from the control (conventional protocol with calculation-based dosing) to the intervention (standardized protocol with age-based dosing), such that all 20 sites will ultimately implement the intervention during the 4-year enrollment period.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Neurologists will assess the primary outcome of seizing on emergency department arrival using a rapid response electroencephalogram (RR-EEG) that is applied to the patient's scalp upon arrival. Site-specific identifiers will not be available to the neurologist when reading the RR-EEG, so they will be masked to whether the patient was treated under the conventional or standardized protocol. Since the participants' parents will likely see how the paramedics select the midazolam dose and may share that with the participant, they will not be masked to the intervention. The paramedics are the care providers, and they will not be masked to the intervention since their medical director must inform them when their seizure treatment protocol switches from the conventional to the standardized protocol. The investigators will not be masked because they will conduct the training of the paramedic trainers at each site between randomization and implementation of the intervention.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT05121324
- Status
- Recruiting
- Sponsor
- Stanford University