USE OF LORAZEPAM FOR THE TREATMENT OF PEDIATRIC STATUS EPILEPTICUS

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。癫痫持续状态 (SE) 是指一个人长时间癫痫发作或一次多次癫痫发作时使用的术语。大多数医生都认为应该立即开始治疗以阻止脑损伤。大多数患者在癫痫发作期间或癫痫发作后不久来到急诊室，治疗通常在急诊室没有癫痫医生在场的情况下开始。应该在这些患者最常接受治疗的地方开展针对这些类型癫痫发作的研究。患有此类癫痫发作的患者会接受药物治疗以阻止癫痫发作。我们认为，通过给予药物，这将有助于患者康复，并减少以后可能发生的脑损伤。我们要研究的药物是一种叫做苯二氮卓类药物。这类药物被认为是治疗SE的最佳药物。这些类型的药物可能有副作用，最严重的是呼吸减慢或停止。呼吸减慢或停止是在急诊室给予这些药物最常见的副作用。关于这些药物对儿童的安全性和有效性的信息很少。我们要研究的药物叫做劳拉西泮。这项研究的主要目标是确定单剂量劳拉西泮在体内的作用。该药物将通过静脉注射给患有癫痫症或有癫痫病史的 3 个月至 18 岁儿童。没有人会因为性别、种族或民族而被排除在外。来自儿科紧急护理应用研究网络 (PECARN) 的 11 名急诊室将参与这项研究。如果患者适合参加本研究、同意参加并且其监护人在听说该研究后愿意签署同意书，则将在不同时间采集一些血液样本。研究开始后 48 小时内，将在不同时间抽取血液。本研究中儿童的监护人将在参加本研究后 7-10 天和 30-40 天接到电话采访。本研究中的儿童只能通过出于研究目的而提供给他们的数字来认识。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Status epilepticus (SE) is a term used when a person has a long seizure or many seizures at one time. Most doctors agree that treatment should be started right away to stop brain damage. Most patients come to an emergency room during or shortly after their seizure and treatment is usually started without a seizure doctor being in the emergency room. A study which looks at these types of seizures should happen where these patients are most often treated. Patients who come to the ER with these types of seizures are treated with drugs to stop the seizure. By giving the medicine we think that this will help the patient get better and will reduce possible brain damage later on. The drug we want to study is a type of drug called benzodiazepines. These kinds of drugs are thought to be the best drugs for the treatment of SE. These types of drug may have side effects, the worst being slowing or stopping of breathing. Slowing or stopping of breathing is the most common side effect of giving these drugs in the emergency room. Information on how safe and how effective these drugs are in children is rare. The drug we want to study is called lorazepam. The main goal of this study is to determine how a single dose of lorazepam behaves in the body. The medicine will be given through the veins to children with seizures or a history of seizures aged from 3 months to 18 years. Nobody will be excluded because of gender, race, or ethnicity. Eleven ERs from the Pediatric Emergency Care Applied Research Network (PECARN) will take part in this study. Patients will have a few blood samples taken at different times if they are suitable for this study, agree to take part and their guardian is willing to sign a consent form after hearing about the study. The blood will be drawn at different times during the next 48 hours after starting the study. Guardians of children in this study will be called by telephone for an interview over the phone 7-10 and 30-40 days after taking part in this study. Children in this study will be known only by numbers that are given to them for study purposes.