Status:
COMPLETED
Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
Lead Sponsor:
Robert Silbergleit
Collaborating Sponsors:
Medical University of South Carolina
University of California, San Francisco
Conditions:
Status Epilepticus
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Seizures are a common medical problem. Although they can be frightening to watch, most seizures are brief and stop by themselves. Seizures that don't stop in seconds or minutes are a dangerous life-th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
1023 Patients enrolled
Trial Details
Trial ID
NCT00809146
Start Date
June 1 2009
End Date
January 1 2011
Last Update
June 17 2016
Active Locations (17)
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1
University of Arizona
Tucson, Arizona, United States, 85742
2
Stanford University
Palo Alto, California, United States, 94304-5777
3
University of California-San Francisco
San Francisco, California, United States, 94110
4
Emory University
Atlanta, Georgia, United States, 30303