Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications

Trial ID or NCT#

NCT00809146

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

James Quinn
James Quinn
Emergency medicine doctor, Pediatric emergency medicine doctor
Professor of Emergency Medicine, Emeritus

Contact us to find out if this trial is right for you.

Contact

Rosen Mann
6507212645

View on ClinicalTrials.gov