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.

Condition	Treatment or Intervention	Phase
Status Epilepticus	Drug: diazepam  Drug: lorazepam	Phase III

Further Study Details: 

Expected Total Enrollment:  210

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Status epilepticus with at least 5 minutes of sustained seizure activity with a depressed level of consciousness, or 2 or more discrete seizures without recovery or consciousness between seizures Verified by bystander or observed by paramedic from San Francisco Department of Health --Prior/Concurrent Therapy-- No chronic benzodiazepines for seizure disorder --Patient Characteristics-- Cardiovascular: Systolic blood pressure at least 100 mm Hg No second- or third- degree atrioventricular block No sustained ectopic tachyrhythmia Pulse rate between 60 and 150 No severe myocardial insufficiency No hypovolemic, cardiogenic, or obstructive shock Pulmonary: No history of asthma No history of chronic obstructive airway disease No history of limited pulmonary reserve Other: No allergy or prior sensitivity to benzodiazepines No distributive shock (e.g., septic, neurogenic, or anaphylactic)

Study chairs or principal investigators

Daniel Lowenstein,  Study Chair,  University of California, San Francisco   

Study ID Numbers:  199/11733; UCSF-69020732504A
Record last reviewed:  December 2001
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004297
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08