USE OF LORAZEPAM FOR THE TREATMENT OF PEDIATRIC STATUS EPILEPTICUS

劳拉西泮用于治疗小儿癫痫持续状态的用途

• 批准号: 7376636
• 负责人: RACHEL M STANLEY
• 金额: $ 0.41万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376636
• 关键词: blood; brain; children; lorazepam; medicine; pulmonary respiration; thinking

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。癫痫持续状态（SE）是一个术语，用于当一个人有长时间癫痫发作或多次癫痫发作在同一时间。大多数医生都认为应该立即开始治疗以防止脑损伤。大多数患者在癫痫发作期间或发作后不久就来到急诊室，通常在没有癫痫医生在场的情况下开始治疗。一项针对这些类型癫痫发作的研究应该发生在这些患者最常接受治疗的地方。带着这些类型的癫痫来急诊室的病人会接受药物治疗来停止癫痫发作。我们认为，通过用药，这将帮助病人好转，并减少以后可能出现的脑损伤。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。减缓或停止呼吸是在急诊室使用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。这项研究的主要目的是确定单剂量的劳拉西泮在体内的作用。该药将通过静脉给予3个月至18岁的癫痫发作或有癫痫病史的儿童。没有人会因为性别、种族或民族而被排除在外。来自儿科急诊护理应用研究网络（PECARN）的11名急诊室将参加本研究。如果患者适合本研究，同意参加，并且其监护人在得知研究后愿意签署同意书，我们将在不同的时间抽取少量血液样本。在研究开始后的48小时内，将在不同时间抽血。本次研究中儿童的监护人将在参与研究后7-10天和30-40天通过电话进行电话访谈。在这项研究中，孩子们只能通过为研究目的而提供的数字来了解他们。