Comparing Acute Pain Management Protocols for Patients with Sickle Cell Disease

描述（由申请人提供）：本研究的目的是改善成人镰状细胞病（SCD）的急诊科（ED）疼痛管理。患者目前到急诊科治疗严重，痛苦的血管闭塞危象（VOC）。没有标准的、基于证据的方法来治疗令人痛苦的VOC。2012年8月，国家心脏、肺和血液研究所发布了基于证据的“镰状细胞病的管理”建议，征求公众意见，这些建议是由专家小组达成共识的。由于缺乏经验数据，大多数针对VOC的建议都是基于共识小组的专业知识。建议包括使用患者特定方案（针对单个患者的特定药物和剂量）或标准VOC镇痛方案。采用NHLBI专家小组推荐的方案，我们将在两个急诊科进行一项试验性随机对照试验，招募77名患者，约160次急诊科就诊。本试验RCT应用的目的是收集设计和执行最终RCT所需的数据，将患者特定方案与SCD标准方案进行比较。研究结果是检查从到达急诊科到出院（回家或住院），住院和其他临床（即疼痛缓解时间，疼痛评分改善，患者满意度）和安全性（呼吸和血流动力学）结果的差异。研究目标是：1。为随机分配到该治疗组的患者制定和实施患者特异性VOC方案；2. 进行一项试验性随机对照试验，以确定进行大型随机对照试验所需的样本量，以比较随机分配到(1)标准SCD特异性镇痛方案（对照组）和(2)患者特异性镇痛方案的受试者从到达到出院、住院、临床和安全结果的疼痛评分减少的差异。3. 通过评估最佳招募和保留策略，以及评估ED提供者（注册护士和医学博士）对协议使用和协议遵守的促进者和障碍的看法，来衡量方法的可行性、协议的可接受性和保真度。完成后，我们将准备进行一项实施特定VOC协议的随机对照试验，或者我们将能够提供额外的证据来支持镰状细胞草案的传播

DESCRIPTION (provided by applicant): The goal of this research is to improve emergency department (ED) pain management for adults with sickle cell disease (SCD). Patients present to the ED for treatment of severe, painful vaso-occlusive crisis (VOC). There is no standard, evidence based approach to treating painful VOC. In August 2012 the National Heart, Lung, and Blood Institute released for public comment their "Management of Sickle Cell Disease" evidence- based recommendations that were developed with consensus panel expertise. Because of a lack of empirical data, most of the recommendations specific to VOC were based on consensus panel expertise. Recommendations included the use of a patient specific protocol (specific agents and doses for an individual patient) or a standard VOC analgesic protocol. Using the NHLBI expert panel recommended protocols, we will conduct a pilot RCT at two EDs and enroll 77 patients with approximately 160 ED visits. The purpose of this pilot RCT application is to collect the data necessary to design and execute a definitive RCT comparing patient specific protocols to a SCD standard protocol. Study outcomes are to examine the difference in the reduction in pain score from arrival in the ED to discharge (home or hospital admission), hospital admission, and other clinical (i.e., time to pain relief, improvement in pain score, patient satisfaction) and safety (respiratory and hemodynamic) outcomes. Study aims are to: 1. Develop and implement patient specific VOC protocols for patients randomized to this treatment arm; 2. Conduct a pilot RCT to determine the necessary sample size needed for a large RCT to compare the difference in reduction in pain score from arrival to discharge, hospitalization , clinical and safety outcomes, between subjects assigned randomly to a (1) standard SCD specific analgesic protocol, (control) and (2) patient-specific analgesic protocols. 3. Measure feasibility of methods and acceptability of and fidelity to protocols by evaluating optimal recruitment and retention strategies, and assessing ED providers (RN and MD) perceptions of facilitators and barriers to protocol use and protocol adherence. Upon completion, we will either be prepared to conduct a RCT implementing a specific VOC protocol or we will be able to provide additional evidence to support dissemination of the draft sickle cell guidelines.