Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Silbergleit
• Collaborators: Medical University of South Carolina; National Institute of Neurological Disorders and Stroke (NINDS); University of California, San Francisco
• Treatments: Anticonvulsants; Lorazepam; Midazolam

Criteria

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