Pediatric Dose Optimization for Seizures in Emergency Medical Services (NCT05121324)
Pediatric Dose Optimization for Seizures in EMS (PediDOSE)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona — Tucson, Arizona
Age range: 6 Months to 13 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- University of Arizona — Tucson, Arizona
- Children's Hospital of Los Angeles — Los Angeles, California
- University of California, Davis — Sacramento, California
- University of California, San Francisco — San Francisco, California
- University of Colorado — Aurora, Colorado
- Children's National Hospital — Washington D.C., District of Columbia
- Emory University — Atlanta, Georgia
- Indiana University — Indianapolis, Indiana
- University of Michigan — Ann Arbor, Michigan
- University at Buffalo — Buffalo, New York
- Mecklenburg EMS — Charlotte, North Carolina
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Oregon Health and Sciences University — Portland, Oregon
- University of Pittsburgh — Pittsburgh, Pennsylvania
- University of Texas Southwestern — Dallas, Texas
- Baylor College of Medicine — Houston, Texas
- University of Utah — Salt Lake City, Utah
- University of Washington — Seattle, Washington
- Medical College of Wisconsin — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (650) 723-3319
Email: mshah5@stanford.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Seizures
- Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures — Winston-Salem, North Carolina
- Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients — New Haven, Connecticut
- Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults — Palo Alto, California
- Modulating Movement Intention Via Cortical Stimulation — New York, New York
- Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy — Gainesville, Florida
- Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases — Boston, Massachusetts
Explore by condition: All Seizures clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.