Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
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ClinicalTrials.gov Identifier: NCT00004297 |
Recruitment Status :
Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Status Epilepticus | Drug: diazepam Drug: lorazepam | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 210 participants |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | November 1995 |
Study Completion Date : | February 1999 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004297
Study Chair: | Daniel Lowenstein | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00004297 |
Other Study ID Numbers: |
199/11733 UCSF-69020732504A |
First Posted: | October 19, 1999 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 2001 |
epilepsy neurologic and psychiatric disorders rare disease seizures status epilepticus |
Lorazepam Status Epilepticus Seizures Neurologic Manifestations Nervous System Diseases Diazepam Anticonvulsants Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Hypnotics and Sedatives Central Nervous System Depressants |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Muscle Relaxants, Central Neuromuscular Agents Anesthetics, Intravenous Anesthetics, General Anesthetics |