Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications

Completed · Phase 3

Conditions studied: Status Epilepticus

In brief

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.

Key facts

Study ID

NCT00809146

Run by

Robert Silbergleit

People needed

1023

Starts

2009-06-01

Expected to finish

2011-01-01

Last updated by the study team

2016-06-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Stanford University — Palo Alto, California, United States
• University of California-San Francisco — San Francisco, California, United States
• Emory University — Atlanta, Georgia, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• New York Presbyterian Hospital — New York, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania/York — Philadelphia, Pennsylvania, United States
• Temple University-Main Line — Philadelphia, Pennsylvania, United States
• University of Texas-Houston — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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