Dataset from Use of Lorazepam for the Treatment of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial of Lorazepam and Diazepam

A randomized, double-blinded trial comparing the efficacy and safety of intravenous lorazepam to diazepam in pediatric patients aged 3 months to less than 18 years treated for status epilepticus (SE) or with a history of SE. For patients in whom SE was not terminated by benzodiazepines, data were collected prospectively regarding subsequent medications, dosing, and effectiveness. Cohort assignment was based on medical history: Cohort 1 included patients presenting to the Emergency Department (ED) in SE with prior informed consent; Cohort 2 included patients presenting to the ED in SE without prior informed consent and enrolled under Exemption from Informed Consent (EFIC). Subjects were stratified by age in each cohort and randomized to receive lorazepam 0.1 mg/kg up to maximum dose 4 mg or diazepam 0.2 mg/kg up to maximum dose 8 mg. A second dose, if required for ongoing convulsions, was half of the first dose. This study was conducted under the Best Pharmaceuticals for Children Act Program.