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镰状细胞病（SCD）成人急诊科（艾德）疼痛管理。患者到艾德接受重度疼痛性血管闭塞危象（VOC）治疗。没有标准的，基于证据的方法来治疗疼痛的VOC。2012年8月，国家心脏、肺和血液研究所发布了他们的“镰状细胞病管理”循证建议，供公众评论，这些建议是在专家组的专业知识基础上制定的。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（针对个体患者的特定药物和剂量）或标准VOC镇痛方案。使用NHLBI专家小组推荐的方案，我们将在两个ED进行一项试点RCT，并招募77例患者，约160次艾德访视。该试验性RCT应用程序的目的是收集设计和执行确定性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艾德到出院（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。研究目的是：1.为随机分配到该治疗组的患者制定并实施患者特定VOC方案; 2.进行一项试验性RCT，以确定大型RCT所需的必要样本量，以比较随机分配至（1）标准SCD特定镇痛方案（对照）和（2）患者特定镇痛方案的受试者之间从抵达至出院、住院、临床和安全性结局疼痛评分降低的差异。3.通过评估最佳招募和保留策略，以及评估艾德提供者（RN和MD）对促进者的看法以及对方案使用和方案遵守的障碍，来衡量方法的可行性以及方案的可接受性和忠诚度。完成后，我们将准备进行一项实施特定VOC方案的RCT，或者我们将能够提供额外证据来支持镰状细胞草案的传播 指南

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.