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Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Status Epilepticus

Intervention: diazepam (Drug); lorazepam (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)

Official(s) and/or principal investigator(s):
Daniel Lowenstein, Study Chair, Affiliation: University of California, San Francisco

Summary

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.

Clinical Details

Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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)

Locations and Contacts

Additional Information

Starting date: November 1995
Last updated: June 23, 2005

Page last updated: August 23, 2015

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