Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

癫痫发作是最常见的原因之一，旁观者呼叫紧急医疗服务（EMS）为一个孩子，目前的做法往往失败，由于剂量不足和延迟交付抗癫痫药物。苯二氮卓类药物，如咪达唑仑，鼻腔注射或肌肉注射是癫痫发作的一线治疗方法。不幸的是，三分之一的癫痫患儿在到达急诊科（ED）时持续发作，因为咪达唑仑剂量不足和延迟未能阻止癫痫发作。持续发作的儿童癫痫发作更难停止，这使他们面临无法呼吸和脑损伤的风险。为了减少这种风险，需要为护理人员配备一种简化的方法，以快速确定和施用治疗剂量的药物。护理人员建议简化咪达唑仑的剂量，消除在压力条件下确定体重剂量时容易出错的顺序计算。标准化的、基于年龄的剂量可能更简单、更快和更有效，而不影响安全性。EMS中癫痫发作的儿科剂量优化（Pedi Dose）研究的总体目标是衡量EMS中咪达唑仑标准剂量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，我们将开展一项大型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治疗儿童癫痫发作。我们相信，在儿童到达急诊科之前，实施这项措施将阻止更多的癫痫发作，而不会增加呼吸衰竭的发生率。本研究的第一个目的是比较标准化EMS咪达唑仑剂量与常规剂量对癫痫发作停止的影响。我们假设，根据年龄给予标准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咪达唑仑剂量后，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常规剂量相比，呼吸缓慢或呼吸缺失没有差异。如果这项研究表明，标准化的、基于年龄的咪达唑仑剂量比目前的做法既安全又有效，那么这项研究的潜在影响是儿科癫痫发作治疗的范式转变，可以很容易地在全国各地的紧急医疗服务（EMS）系统中实施。

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.