Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

描述（由申请人提供）：急诊科（艾德）的疼痛管理是一项重大的护理和医疗挑战。艾德疼痛管理不足已被充分记录。阿片类镇痛药构成急性疼痛的标准治疗，然而，在ED中最佳使用阿片类药物存在许多障碍。这些障碍包括高患者与工作人员比率、急性病患者的同时需求、阿片类药物需求的个体间差异大、剂量相关毒性以及缺乏提供个性化疼痛管理的资源。病人自控镇痛（PCA）已成功地用于术后疼痛管理。在这种情况下，患者通常接受吗啡滴定，直到患者感到舒适，然后开始PCA。考虑到在艾德中提供这种强化管理的障碍，PCA有可能通过允许向所有患者给予阿片类药物的初始推注剂量，然后由患者启动需求给药来改善疼痛管理。该方案是一种新的方法，可以弥补初始（通常不足）剂量的疼痛缓解与具有更高镇痛需求的患者所需的疼痛缓解之间的差距。它也可用于延长艾德住院时间的患者随时间推移维持镇痛。PCA在艾德中的应用最少;很少有研究严格评估其对疗效和安全性的影响。该研究的目的是：1）评估PCA在艾德中的有效性和安全性; 2）比较两种PCA给药方案。210例年龄在18 - 65岁之间的需要静脉阿片类镇痛的腹痛艾德患者将入组一项随机、双盲、安慰剂对照研究。所有患者将接受0.1 mg/kg吗啡的负荷剂量。然后，他们将接受：1.0 mg，1.5 mg吗啡或安慰剂PCA需求给药，每6分钟一次。首次给予吗啡后每半小时记录一次数字评定量表，最长2小时，用于测量疼痛强度。研究护士将持续监测血氧饱和度、呼吸频率和收缩压。所有患者都可以根据临床工作人员的决定接受吗啡补充。主要终点是疼痛强度从基线到30分钟的变化和不良事件的发生率。将在方差分析后进行预先计划的组间比较。如果发生基线差异，将使用多变量统计量进行调整。次要终点是两小时观察期内的疼痛、临床工作人员给予的额外镇痛药的数量和剂量、恶心、呕吐和肠炎的发生率。我们假设，PCA将提供上级的镇痛效果，而不会比临床工作人员自行决定补充的单次剂量更高的不良事件发生率;并且1.5 mg的需求剂量将上级1.0 mg，而不会发生更多的不良事件。PCA的应用，艾德构成了一个新的和有前途的方法，以改善疼痛管理，在这个充满挑战的环境。公共卫生相关性：本研究旨在提供急诊科使用病人自控镇痛治疗腹痛的安全性和有效性的初步数据。它代表了一种新的方法来管理疼痛在这个忙碌和要求设置。

DESCRIPTION (provided by applicant): Management of pain in the Emergency Department (ED) is a major nursing and medical challenge. Inadequate ED pain management has been well documented. Opioid analgesics constitute the standard treatment of acute pain, however there are numerous obstacles to optimal use of opioids in the ED. These obstacles include high patient-to-staff ratios, the simultaneous demands of acutely ill patients, large inter- individual variability in opioid requirement, dose related toxicity, and lack of resources to provide individualized pain management. Patient Controlled Analgesia (PCA) has been used successfully in post-operative pain management. In that setting, patients typically receive titration of morphine until the patient is comfortable and then PCA is initiated. Given the barriers to delivering this intensive management in the ED, PCA has the potential to improve pain management by allowing an initial bolus dose of opioid to be administered to all patients, followed by patient-initiated demand dosing. This regimen is a novel means to bridge the gap between pain relief from an initial, often inadequate dose and that desired by patients with higher analgesic requirements. It can also be used to maintain analgesia over time for patients with extended ED stays. PCA has had minimal application in the ED; and few studies have rigorously assessed its impact on efficacy and safety. The aims of the study are to: 1) assess the efficacy and safety of PCA in the ED; and 2) compare two PCA dosing regimens. 210 ED patients ages 18 through 65 years with abdominal pain requiring intravenous opioid analgesia will be enrolled in a randomized double-blind placebo-controlled study. All patients will receive a loading dose of 0.1 mg/kg morphine. They will then receive either: 1.0 mg, 1.5 mg of morphine or placebo PCA demand dosing available every 6 minutes. A numerical rating scale recorded every half hour up to 2 hours after initial administration of morphine will be used to measure pain intensity. Oxygen saturation, respiratory rate, and systolic blood pressure will be monitored continuously by the study nurse. All patients can receive morphine supplementation as needed at the discretion of the clinical staff. Primary endpoints are change in pain intensity from baseline to 30 minutes and incidence of adverse events. Pre-planned comparisons between the groups will be performed following analysis of variance. Multivariate statistics will be used to adjust for baseline differences should they occur. Secondary endpoints are pain over the total two hour observation period, number and dose of additional analgesics administered by the clinical staff, incidence of nausea, vomiting, and pruritis. We hypothesize that PCA will provide superior analgesia without a greater incidence of adverse events than a single dose that can be supplemented at the discretion of the clinical staff; and that demand dosing of 1.5 mg will be superior to 1.0 mg without more adverse events. The application of PCA to the ED constitutes a novel and promising approach to improving pain management in this challenging environment. PUBLIC HEALTH RELEVANCE: This study aims to provide preliminary data about the safety and efficacy of patient controlled analgesia for management of abdominal pain the Emergency Department. It represents a novel approach to managing pain in this busy and demanding setting.