Pediatric Dose Optimization for Seizures in Emergency Medical Services
Public ClinicalTrials.gov record NCT05121324. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pediatric Dose Optimization for Seizures in EMS (PediDOSE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05121324
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 6,700 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 13 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 7, 2022
- Primary completion
- Jul 30, 2026
- Completion
- Sep 29, 2026
- Last update posted
- Sep 29, 2025
2022 – 2026
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | Recruiting |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | Recruiting |
| University of California, Davis | Sacramento | California | 95817 | Recruiting |
| University of California, San Francisco | San Francisco | California | 94143 | Recruiting |
| University of Colorado | Aurora | Colorado | 80045 | Recruiting |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Emory University | Atlanta | Georgia | 30322 | Recruiting |
| Indiana University | Indianapolis | Indiana | 46202 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48105 | Recruiting |
| University at Buffalo | Buffalo | New York | 14203 | Recruiting |
| Mecklenburg EMS | Charlotte | North Carolina | 28226 | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Recruiting |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Recruiting |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | Recruiting |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| University of Texas Southwestern | Dallas | Texas | 75235 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| University of Utah | Salt Lake City | Utah | 84108 | Recruiting |
| University of Washington | Seattle | Washington | 98104 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05121324, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05121324 live on ClinicalTrials.gov.