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Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
Not Recruiting
Trial ID: NCT00809146
Purpose
The goal of this non-inferiority trial is to determine which type of routine care is the best
for paramedics to stop someone from seizing.
Official Title
A Double-blind Randomized Clinical Trial of the Efficacy of IM Midazolam Versus IV Lorazepam in the Pre-hospital Treatment of Status Epilepticus by Paramedics
Stanford Investigator(s)
James Quinn
Professor of Emergency Medicine, Emeritus
Eligibility
Inclusion Criteria:
- Paramedics or reliable witnesses verify 5 minutes of either continuous seizure
activity or of repeated convulsive seizure activity where the patient does not regain
consciousness (operationally defined as meaningful speech or obeying commands) between
seizures.
- Patient is still seizing at the time of paramedic treatment with study medications.
- Estimated weight equal to or greater than 13 kg.
- Subject to be transported to a RAMPART participating hospital.
Exclusion Criteria:
- Major trauma as the precipitant of the seizure
- Hypoglycemia (as defined by local EMS protocol or a glucose < 60 mg/dL)
- Known allergy to midazolam or lorazepam
- Cardiac arrest or heart rate (HR) <40 beats per minute
- Sensitivity to benzodiazepines
- Medical alert tag marked with "RAMPART declined"
- Prior treatment of this seizure with diazepam autoinjector as part of another study
- Known pregnancy
- Prisoners
Intervention(s):
drug: Intramuscular route of active treatment
drug: Intravenous route of active treatment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Rosen Mann
6507212645