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Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

EMS 中癫痫发作的儿科剂量优化 (PediDOSE)

基本信息

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
项目类别：
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

项目摘要

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呼叫紧急医疗服务（EMS）的最常见原因之一，目前的做法经常由于剂量不足和延迟交付抗癫痫药物而失败。苯二氮卓类药物，如咪达唑仑，通过鼻腔或肌肉注射给药，是癫痫发作的一线治疗药物。不幸的是，三分之一的积极癫痫发作的儿童在到达急诊室（艾德）时持续癫痫发作，因为咪达唑仑剂量不足和延迟未能阻止癫痫发作。继续癫痫发作的儿童更难停止癫痫发作，这使他们面临无法呼吸和脑损伤的风险。降低这种风险需要为护理人员配备一种快速确定和管理治疗剂量的药物的简化方法。护理人员建议通过消除在压力条件下确定基于体重的剂量所需的易出错的顺序计算来简化咪达唑仑剂量。标准化的、基于年龄的给药可能更简单、更快、更有效，而不会影响安全性。EMS中癫痫发作的儿科剂量优化（Pedi DOSE）研究的总体目的是测量标准化EMS咪达唑仑给药对癫痫发作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，在全国20个EMS系统中实施标准化的、基于年龄的咪达唑仑给药。我们相信，实施将阻止更多的癫痫发作之前，儿童到达ED没有增加呼吸衰竭率。本研究的第一个目的是比较标准化EMS咪达唑仑给药与传统给药对癫痫发作停止的影响。我们假设，根据年龄给予标准化的咪达唑仑剂量将使护理人员比目前的常规剂量更快地阻止儿童癫痫发作。本研究的第二个目的是确定在实施标准化EMS咪达唑仑给药后儿童停止呼吸或呼吸无效的频率。我们假设，标准化EMS咪达唑仑剂量与当前实践中相对于常规剂量的呼吸缓慢或呼吸缺失无差异。如果这项研究表明，标准化的，基于年龄的咪达唑仑剂量是安全的，比目前的做法更有效，这项研究的潜在影响是在治疗小儿癫痫发作，可以很容易地在全国各地的紧急医疗服务（EMS）系统实施的范式转变。