Status Epilepticus Clinical Trial
Official title:
Use Of Lorazepam For The Treatment Of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial Of Lorazepam And Diazepam
Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam be performed. The study will show whether one drug is more effective and safe than the other.
Textbooks and expert opinion recommend both diazepam and lorazepam as initial therapy for
children in status epilepticus (SE) and provide recommended doses that are commonly used.
However, unlike diazepam, lorazepam is only FDA-approved for treatment for SE in patients
over 18 years of age. Despite this fact, many experts support the use of lorazepam over
diazepam in pediatric SE. Increased duration of action, increased effectiveness in
terminating SE, and a lower incidence of respiratory depression have been cited as potential
advantages of lorazepam over diazepam. However, data to support firm recommendations for one
medication over another are lacking. Thus, either diazepam (FDA-approved) or lorazepam can
be considered first-line agents for pediatric SE, and the physician's choice of agent
depends on local practice patterns and individual treatment styles. In the prehospital
(Emergency Medical Services) setting, diazepam is commonly chosen because of a longer shelf
life without refrigeration.
The purpose of this study is to determine the differences in efficacy and safety between
these two commonly used benzodiazepines, as requested by the FDA under the Best
Pharmaceuticals for Children Act, using the Exception from Informed Consent provided by the
FDA.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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