Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||November 1995|
|Estimated Study Completion Date:||February 1999|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004297
|Study Chair:||Daniel Lowenstein||University of California, San Francisco|