Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

EMS 中癫痫发作的儿科剂量优化 (PediDOSE)

• 批准号: 10211793
• 负责人: Manish Ishwar Shah
• 金额: $ 456.17万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10211793
• 关键词: Accident and Emergency department; Address; Adherence; Age; Ambulances; Applied Research; Area; Benzodiazepines; Brain Injuries; Breathing; Caring; Child; Childhood; Country; Dose; Early treatment; Effectiveness; Electroencephalogram; Electroencephalography; Emergency Care; Emergency medical service; Frequencies; Goals; Guideline Adherence; Injections; Intramuscular; Intravenous; Literature; Manuscripts; Measures; Midazolam; Morbidity - disease rate; Multicenter Studies; Muscle; Nose; Outcome; Outcomes Research; Overdose; Paramedical Personnel; Pharmaceutical Preparations; Pre-hospital setting; Protocols documentation; Recurrence; Regimen; Research; Research Priority; Respiratory Failure; Risk; Route; Safety; Seizures; Standardization; System; Technology; Testing; Therapeutic; Treatment Effectiveness; Weight; adverse outcome; base; care systems; design; evidence based guidelines; improved; improved outcome; innovation; mortality; novel; pediatric emergency; pediatric patients; primary outcome; rapid technique; rectal; response

Seizures are one of the most common reasons why bystanders call Emergency Medical Services (EMS) for a child, and current practice frequently fails due to under-dosing and delayed delivery of anti-seizure medication. Benzodiazepines, such as midazolam, given in the nose or as a muscular injection are the first line treatment for seizures. Unfortunately, one-third of actively seizing children have ongoing seizures on arrival to the emergency department (ED) because an inadequate and delayed dose of midazolam fails to stop seizures. Children who continue to seize have seizures that are harder to stop, and this puts them at risk for not breathing and having brain damage. Reducing this risk requires equipping paramedics with a simplified method for rapidly determining and administering a therapeutic dose of medication. Paramedics suggest simplifying midazolam dosing by eliminating the error-prone, sequential calculations required to determine a weight-based dose under stressful conditions. Standardized, age-based dosing may be simpler, faster and more effective, without compromising safety. The overall objective of the Pediatric Dose Optimization for Seizures in EMS (Pedi DOSE) study is to measure the impact of standardized EMS midazolam dosing on seizure treatment effectiveness and safety. To achieve this objective, we will conduct a large EMS trial to implement standardized, age-based midazolam dosing for pediatric seizures in 20 EMS systems nationally. We believe that implementation will stop more seizures before children arrive at EDs without increasing respiratory failure rates. The first aim of this study is to compare the impact of standardized EMS midazolam dosing relative to conventional dosing on seizure cessation. We hypothesize that giving a standardized midazolam dose based on age will allow paramedics to stop a child’s seizure faster than conventional dosing with current practice. The second aim of this study is to determine how often children stop breathing or ineffectively breathe after implementation of standardized EMS midazolam dosing. We hypothesize that standardized EMS midazolam dosing is associated with no difference in slow or absent breathing relative to conventional dosing with current practice. If this study demonstrates that standardized, age-based midazolam dosing is both safe and more effective than current practice, the potential impact of this study is a paradigm shift in the treatment of pediatric seizures that can be easily implemented in emergency medical services (EMS) systems across the country.

癫痫发作是旁观者为儿童寻求紧急医疗服务 (EMS) 的最常见原因之一，而目前的做法经常因鼻内给予的抗癫痫药物（例如咪达唑仑）剂量不足和延迟输送而失败。不幸的是，三分之一的癫痫发作儿童在到达急诊科 (ED) 后仍持续癫痫发作，因为咪达唑仑的剂量不足且延迟。持续癫痫发作的儿童癫痫发作更难停止，这使他们面临呼吸困难和脑损伤的风险，需要为护理人员配备一种简化的方法，以快速确定药物的治疗剂量。建议通过消除在压力条件下确定基于体重的剂量所需的容易出错的顺序计算来简化咪达唑仑的剂量，标准化的基于年龄的剂量可能会更简单、更快和更有效，而不会影响。 EMS 中癫痫发作的儿科剂量优化 (Pedi DOSE) 研究的总体目标是衡量标准化 EMS 咪达唑仑剂量对癫痫治疗有效性和安全性的影响。为了实现这一目标，我们将进行一项大型 EMS 试验来实施。在全国 20 个 EMS 系统中针对儿童癫痫发作采用标准化、基于年龄的咪达唑仑剂量。我们相信，该措施的实施将在儿童到达急诊室之前阻止更多的癫痫发作，而不会增加呼吸衰竭率。本研究的目的是比较标准化 EMS 咪达唑仑剂量相对于常规剂量对停止癫痫发作的影响，我们认为根据年龄给予标准化咪达唑仑剂量将使护理人员比常规剂量更快地停止儿童癫痫发作。本研究的目的是确定实施标准化 EMS 咪达唑仑剂量后儿童停止呼吸或无效呼吸的频率。我们认为标准化 EMS 咪达唑仑剂量与不相关。与当前实践中的常规剂量相比，缓慢或呼吸困难的差异如果这项研究证明标准化的、基于年龄的咪达唑仑剂量比当前的实践既安全又更有效，那么这项研究的潜在影响是治疗模式的转变。小儿癫痫发作可以在全国的紧急医疗服务 (EMS) 系统中轻松实施。