Study comparing efficacy and safety of diazepam and lorazepam, two commonly used drugs for the treatment of seizures in children
Summary
Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used as initial therapy for children with seizures, is not labeled for this use by the FDA. Despite this fact, many experts support the use of lorazepam over diazepam for seizures in children, citing longer duration, increased effectiveness, and a lower incidence of respiratory depression. The FDA requested that a study be performed comparing lorazepam with diazepam, a drug that is labeled by the FDA for this indication. The study will show whether one drug is more effective and safe than the other.
View study data for diazepam on NICHD's Data and Specimen Hub (DASH).
Publications
- Population Pharmacokinetics and Exploratory Exposure-Response Relationships of Diazepam in Children Treated for Status EpilepticusCPT Pharmacometrics & Systems Pharmacology • November 2018 Access article on PubMed. Ku LC, Hornik CP, Beechinor RJ, Chamberlain JM, Guptill JT, Harper B, Capparelli EV, Martz K, Anand R, Cohen-Wolkowiez M, Gonzalez D; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. Diazepam is labeled for status epilepticus (SE) in children, but there are limited ...
- Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status EpilepticusClinical Pharmacokinetics • August 2017 Access article on PubMed. Gonzalez D, Chamberlain JM, Guptill JT, Cohen-Wolkowiez M, Harper B, Zhao J, Capparelli EV; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to ...
OVERVIEW
Status:
Clinical study report submitted to FDA
ClinicalTrials.gov Identifier:
NCT00621478
NICHD Data and Specimen Hub (DASH):
Diazepam
Principal Investigator:
James Chamberlain, MD
Children's National, Washington, DC
Results-at-a-Glance for Lorazepam
Results-at-a-Glance for Diazepam
Label Change
Diazepam is commonly used to treat children with status epilepticus. Updated label changes included pharmacokinetic information and dosing recommendations for children 3 months to 17 years of age.