Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

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，目前的做法经常因抗癫痫药物剂量不足和延迟交付而失败。苯二氮类药物，如咪达唑仑，在鼻腔内或肌肉注射是治疗癫痫的一线药物。不幸的是，三分之一的积极发作的儿童在到达急诊科(ED)时仍有癫痫发作，因为不足和延迟的咪达唑仑剂量未能阻止癫痫发作。持续癫痫发作的儿童癫痫发作更难阻止，这使他们面临呼吸停止和脑损伤的风险。要降低这种风险，需要为护理人员配备一种快速确定和实施治疗性用药剂量的简化方法。护理人员建议通过消除在压力条件下确定基于重量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更简单、更快、更有效，而不会影响安全性。儿科EMS癫痫剂量优化(PEDI剂量)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，在全国20个EMS系统中实施标准化的、基于年龄的咪达唑仑剂量治疗儿童癫痫发作。我们相信，实施这一措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的发生率。这项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允许医护人员比目前做法的传统剂量更快地阻止儿童癫痫发作。这项研究的第二个目的是确定在实施标准化的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，标准化的EMS咪达唑仑剂量与目前的常规剂量相比，呼吸缓慢或消失的情况没有差异。如果这项研究证明了标准化的、基于年龄的咪达唑仑剂量比目前的做法既安全又更有效，那么这项研究的潜在影响是儿科癫痫治疗的范式转变，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.