Optimizing seizure treatment for children in ambulances
Pediatric Dose Optimization for Seizures in EMS (PediDOSE)
This study is testing a new way for paramedics to treat seizures in children during ambulance rides to see if it works better than the usual methods.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 6700 (estimated) |
| Ages | 6 Months to 13 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 20 sites (Tucson, Arizona and 19 other locations) |
| Trial ID | NCT05121324 on ClinicalTrials.gov |
What this trial studies
The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study aims to enhance the treatment of seizures in children by paramedics during ambulance transport. It addresses the common issue of under-dosing and delayed medication delivery, which can lead to continued seizures upon arrival at emergency departments. The study compares a standardized seizure protocol using muscular injection or nasal spray against conventional methods to determine effectiveness and safety in pediatric patients. This research is crucial as most existing studies have focused on adults, highlighting the need for tailored approaches for children.
Who should consider this trial
Good fit: Ideal candidates include children actively seizing who are under the care of paramedics and being transported by participating EMS agencies.
Not a fit: Patients with a history of benzodiazepine allergy, known or presumed pregnancy, or severe growth restriction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve seizure management in children during emergency situations, leading to better outcomes.
How similar studies have performed: While similar approaches have been tested in adults, this study represents a novel effort to optimize seizure treatment specifically for pediatric patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tucson, Arizona and 19 other locations
- University of Arizona — Tucson, Arizona, United States (Recruiting)
- Children's Hospital of Los Angeles — Los Angeles, California, United States (Recruiting)
- University of California, Davis — Sacramento, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Children's National Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University at Buffalo — Buffalo, New York, United States (Recruiting)
- Mecklenburg EMS — Charlotte, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Oregon Health and Sciences University — Portland, Oregon, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern — Dallas, Texas, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Manish I Shah, MD, MS — Stanford University
- Study coordinator: Manish I Shah, MD, MS
- Email: mshah5@stanford.edu
- Phone: 650-723-3319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.