Status Epilepticus Clinical Trial
OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and
complications of diazepam and lorazepam given intravenously as prehospital therapy to
patients in status epilepticus.
II. Determine the effect of prehospital therapy on the incidence of status epilepticus at
the subsequent emergency department admission.
III. Establish whether prehospital therapy alters hospital management of these patients and
ultimately affects patient outcome.
PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are
stratified by center.
Patients en route to the hospital in a San Francisco Department of Health Paramedic Division
ambulance are randomly assigned to 1 of 3 treatment groups. Informed consent is waived due
to impaired consciousness.
Patients receive intravenous diazepam, lorazepam, or placebo during transport. The patient
is re-treated if the seizure is sustained after the first dose or recurs after the first
dose without the patient regaining consciousness.
Upon arrival at the hospital, all patients receive the standard status epilepticus treatment
in use at that site.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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