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

Data on anti-epileptic medication levels
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.

抗癫痫药物用药相关数据
研究概况
本研究为一项随机双盲试验，旨在对比静脉用劳拉西泮（lorazepam）与地西泮（diazepam）治疗3月龄至18岁以下癫痫持续状态（Status Epilepticus, SE）患者或有癫痫持续状态病史的儿科患者的疗效与安全性。对于苯二氮䓬类药物未能终止癫痫持续状态的患者，研究人员前瞻性收集了其后续用药方案、给药剂量及治疗有效性相关数据。
队列分组基于患者病史：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（Emergency Department, ED）就诊、未获得预先知情同意且通过知情同意豁免（Exemption from Informed Consent, EFIC）流程入组的癫痫持续状态患者。
两个队列均按年龄进行分层，随后将受试者随机分配至劳拉西泮组（给药剂量为0.1mg/kg，最大剂量不超过4mg）或地西泮组（给药剂量为0.2mg/kg，最大剂量不超过8mg）。若患者仍有持续性惊厥发作需追加给药，则追加剂量为首剂剂量的一半。
本研究依托《儿童最佳药物法案》项目开展。
研究纳入标准为3月龄至18岁以下的癫痫持续状态患儿。由于本研究采用知情同意豁免流程开展，最终入组了3名年龄超过18岁的受试者。