Study Summary
This trial is designed to improve how paramedics treat seizures in children by making the midazolam dose age-based.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Between arrival to the emergency department and 10 minutes after arrival
Between arrival to the emergency department and 10 minutes after arrival
Seizing on emergency department arrival
Between paramedic arrival on scene until 30 minutes after emergency department arrival
Respiratory failure
Hour 4
Depressed level of consciousness
Hour 24
Life-threatening cardiac arrhythmia
Life-threatening hypotension
Hour 24
Time to seizure cessation in the emergency department
Hour 1
Dose/route adherence
Time to first midazolam administration
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
6000 Total Participants · 2 Treatment Groups
Primary Treatment: Standardized seizure protocol · No Placebo Group · Phase 3
Intervention
Drug
Experimental Group · 1 Intervention: Standardized seizure protocol · Intervention Types: DrugControl
Drug
ActiveComparator Group · 1 Intervention: Conventional seizure protocol · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: between arrival to the emergency department and 10 minutes after arrival
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,261 Previous Clinical Trials
448,962 Total Patients Enrolled
37 Trials studying Seizures
11,956 Patients Enrolled for Seizures
Baylor College of MedicineLead Sponsor
923 Previous Clinical Trials
5,982,049 Total Patients Enrolled
2 Trials studying Seizures
669 Patients Enrolled for Seizures
University of UtahOTHER
1,003 Previous Clinical Trials
1,779,154 Total Patients Enrolled
3 Trials studying Seizures
906 Patients Enrolled for Seizures
Manish I Shah, MD, MSPrincipal InvestigatorBaylor College of Medicine
Eligibility Criteria
Age 6 - 13 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:, all patients were then transported by helicopter to a Level I trauma center
The paramedic saw that the person was having a seizure, no matter what type it was or how long it lasted.
A patient is being carefully watched by a paramedic.
References
- Carey, John M., Jonathan R. Studnek, Lorin R. Browne, Daniel G. Ostermayer, Thomas Grawey, Stephanie Schroter, E. Brooke Lerner, and Manish I. Shah. 2019. “Paramedic-identified Enablers of and Barriers to Pediatric Seizure Management: A Multicenter, Qualitative Study”. Prehospital Emergency Care. Informa UK Limited. doi:10.1080/10903127.2019.1595234.
- Shah, Manish I., Daniel G. Ostermayer, Lorin R. Browne, Jonathan R. Studnek, John M. Carey, Chelsea Stanford, Nicole Fumo, and E. Brooke Lerner. 2020. “Multicenter Evaluation of Prehospital Seizure Management in Children”. Prehospital Emergency Care. Informa UK Limited. doi:10.1080/10903127.2020.1788194.
- Shah, Manish I., Charles G. Macias, Peter S. Dayan, Tasmeen S. Weik, Kathleen M. Brown, Susan M. Fuchs, Mary E. Fallat, Joseph L. Wright, and Eddy S. Lang. 2013. “An Evidence-based Guideline for Pediatric Prehospital Seizure Management Using GRADE Methodology”. Prehospital Emergency Care. Informa UK Limited. doi:10.3109/10903127.2013.844874.
- Manish Shah, MD 2022. "Pediatric Dose Optimization for Seizures in Emergency Medical Services". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05121324.
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