Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

描述（由申请人提供）：急诊室（ED）疼痛管理不足是有据可查的。最佳的疼痛治疗需要频繁的疼痛评估和阿片类药物滴定到有效剂量，因为个体之间的需求差异很大。然而，在这种情况下，由于患者与护士和医生的比例很高，以及患者的多重紧急竞争需求，很难提供滴定。患者自控镇痛（PCA）有可能允许ED患者积极参与疼痛管理，允许自我滴定到所需的疼痛缓解水平。我们小组最近完成的一项由国家临床研究中心资助的随机临床试验（RCT）为PCA在单个急诊科治疗腹痛患者的有效性和安全性提供了有希望的初步支持，该急诊科有专门的研究护士和给所有患者的标准负荷剂量。目的：评估PCA改善ED疼痛管理的能力。具体目的：1)比较参与临床护理的护士对多个研究部位急性疼痛的ED患者进行PCA和非PCA阿片类镇痛的有效性和安全性。主要的假设是，随着时间的推移，疼痛会有更大的减轻，并且随机分配到的患者的安全性相似

DESCRIPTION (provided by applicant): Inadequate Emergency Department (ED) pain management is well-documented. Optimal treatment of pain requires frequent pain assessment and opioid titration to effective dose due to large inter- individual variability in requirement. However titration is difficult to provide in this setting due to high patient to nurse and physicia ratios and multiple urgent competing patient demands. Patient controlled analgesia (PCA) has the potential to allow ED patients to actively participate in pain management by allowing self-titration to desired level of pain relief. An NINR funded randomized clinical trial (RCT) recently completed by our group provides promising preliminary support for the efficacy and safety of PCA for patients with abdominal pain at a single ED with a dedicated research nurse and standard loading dose given to all patients. Objective: To assess the ability of PCA to improve ED pain management Specific aims: 1) To compare the effectiveness and safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver the intervention to a broad group of ED patients with acute pain at multiple study sites. The primary hypothesis is that there will be a greater decline in pain over time and similar safety in patients randomized to receive PCA compared to patients receiving standard opioid analgesia. 2) To describe the feasibility of PCA in terms of patient and provider acceptance, resource utilization and cost associated with implementation and use. Innovation: PCA represents a novel shift from the current provider-driven model of ED pain management to one in which the patient is an active participant. Few prior studies have evaluated ED PCA and no systematic evaluation of time and resources exists. Methodology: An RCT will be performed at 3 clinical centers. 750 patients with acute pain warranting IV opioid administration will be randomized to receive usual opioid analgesia determined by the provider or PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes). Pain intensity will be measured by a numerical rating scale recorded every half hour up to 2 hours after initial opioid administration. Primary endpoints are rate of change in pain intensity from 30 minutes after initial administration of opioid to 2 hours as suggested by the results of the preliminary study and incidence of adverse events. PCA will also be compared to non-PCA opioid analgesia assessed at the end of the 2 hour study period by patient satisfaction with pain management; RN assessment of time efficiency/ease of use and satisfaction with pain management; and physician satisfaction with pain management. Resource utilization and cost associated with implementation and use of PCA in the ED setting will be assessed by total RN time spent on pain management per patient; pharmacy preparation time per patient; material cost per patient and RN and MD training time necessary for PCA implementation. Significance: If PCA is demonstrated to be effective, safe, and associated with patient and provider acceptance and acceptable resource utilization, it has the potential to significantly improve ED pain management.