Standardized seizure protocol for Seizures

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
SeizuresStandardized seizure protocol - Drug
Eligibility
6 - 13
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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: Drug
Control
Drug
ActiveComparator Group · 1 Intervention: Conventional seizure protocol · Intervention Types: Drug

Trial 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.