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

Data on examination for aspiration
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.

误吸相关检查数据
研究概况
本研究为一项随机双盲临床试验，旨在对比静脉注射劳拉西泮与地西泮，用于治疗3月龄至18岁以下、因癫痫持续状态（status epilepticus, SE）就诊或有SE病史的儿科受试者的疗效与安全性。对于癫痫持续状态未被苯二氮䓬类药物终止的受试者，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。
队列分组基于受试者病史制定：队列1纳入急诊科（Emergency Department, ED）就诊时罹患SE且已获得预先知情同意的受试者；队列2纳入急诊科就诊时罹患SE但未获得预先知情同意，依据豁免知情同意（Exemption from Informed Consent, EFIC）流程纳入的受试者。
两个队列均按年龄对受试者进行分层，随后将其随机分配至两组，分别接受劳拉西泮（0.1mg/kg，最大剂量4mg）或地西泮（0.2mg/kg，最大剂量8mg）治疗。若受试者仍有持续性惊厥需追加给药，则第二次给药剂量为首剂的一半。
本研究依据《儿童最佳药品法案》（Best Pharmaceuticals for Children Act）项目开展。本研究的纳入对象为3月龄至18岁以下的癫痫持续状态患儿。由于本研究采用豁免知情同意程序，最终纳入了3名年龄超过18岁的受试者。