Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Status Epilepticus |
Drug: diazepam Drug: lorazepam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 210 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004297 History of Changes |
| Other Study ID Numbers: | 199/11733, UCSF-69020732504A |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Office of Rare Diseases (ORD):
|
epilepsy neurologic and psychiatric disorders rare disease seizures status epilepticus |
Additional relevant MeSH terms:
|
Status Epilepticus Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Diazepam Lorazepam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Gastrointestinal Agents Hypnotics and Sedatives Central Nervous System Depressants Muscle Relaxants, Central Neuromuscular Agents Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013