Status2 Demography Dataset in Use of Lorazepam for the Treatment of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial of Lorazepam and Diazepam

Data on demographics
Study Description
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. Children ages 3 months to less than 18 years with status epilepticus. Because the study was conducted under Exception from Informed Consent, three participants >18 years old were enrolled.

人口统计学相关数据集
研究描述
本研究为一项随机双盲试验，旨在对比静脉注射劳拉西泮（lorazepam）与地西泮（diazepam）在3月龄至18岁以下儿科患者中的疗效与安全性，该类患者因癫痫持续状态（status epilepticus, SE）接受治疗或存在癫痫持续状态病史。
对于苯二氮䓬类药物（benzodiazepines）未能终止癫痫持续状态的患者，研究人员前瞻性收集其后续用药方案、给药剂量及治疗有效性相关数据。
队列分组依据患者病史进行划分：队列1纳入急诊科（Emergency Department, ED）就诊且已获得预先知情同意的癫痫持续状态患者；队列2纳入急诊科就诊且未获得预先知情同意、通过知情同意豁免（Exemption from Informed Consent, EFIC）流程入组的癫痫持续状态患者。
两个队列均按年龄分层，并被随机分配接受劳拉西泮治疗（剂量为0.1mg/kg，最大给药剂量为4mg）或地西泮治疗（剂量为0.2mg/kg，最大给药剂量为8mg）。若患者仍存在持续惊厥发作需追加给药，则第二剂剂量为首剂的一半。
本研究依据《儿童最佳药品法案》（Best Pharmaceuticals for Children Act）项目开展。
本研究原定入组对象为3月龄至18岁以下的癫痫持续状态患儿，但因本研究采用知情同意豁免流程，最终纳入了3名年龄超过18岁的受试者。