Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

急诊科病人自控镇痛的安全性和有效性

• 批准号: 7694323
• 负责人: Polly Ellen Bijur
• 金额: $ 11.33万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-29 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7694323
• 关键词: Abdominal Pain; Absence of pain sensation; Accident and Emergency department; Acute Pain; Adverse event; Age; Analgesics; Analysis of Variance; Blood Pressure; Bolus Infusion; Clinical; Crowding; Data; Discipline of Nursing; Dose; Double-Blind Method; Enrollment; Ensure; Environment; Foundations; Future; Goals; Hour; Incidence; Individual; Infusion Pumps; Intravenous; Measures; Medical; Monitor; Morphine; Nausea and Vomiting; Nurses; Opioid; Opioid Analgesics; Oxygen; Pain; Pain management; Patient-Controlled Analgesia; Patients; Pharmaceutical Preparations; Physicians; Placebos; Postoperative Pain; Postoperative Period; Provider; Pruritus; Random Allocation; Randomized; Research; Resources; Safety; Supplementation; Time; Titrations; Toxic effect; Treatment Protocols; Upper arm; comparative efficacy; improved; novel; novel strategies; placebo controlled study; public health relevance; respiratory; standard care; statistics

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.

描述(申请人提供)：在急诊科(ED)的疼痛管理是一个主要的护理和医学挑战。不充分的ED疼痛管理已经被很好地记录下来了。阿片类镇痛剂是急性疼痛的标准治疗方法，但在急诊室最佳使用阿片类药物存在许多障碍。这些障碍包括患者与工作人员的高比率、急性疾病患者的同时需求、阿片类药物需求的巨大个体差异、与剂量相关的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)已成功地应用于术后疼痛控制。在这种情况下，患者通常会接受吗啡滴定，直到患者感到舒适，然后开始自控镇痛。考虑到在急诊室实施这种强化管理的障碍，PCA有可能通过允许向所有患者提供初始剂量的阿片类药物，然后是患者发起的按需剂量来改善疼痛管理。这种方案是一种新的方法，可以弥合最初的、通常是不足的剂量的疼痛缓解与有更高止痛要求的患者所希望的疼痛之间的差距。对于ED停留时间较长的患者，它也可用于维持一段时间的镇痛。PCA在急诊中的应用很少，也很少有研究严格评估其对疗效和安全性的影响。本研究的目的是：1)评价自控镇痛在ED中的有效性和安全性；2)比较两种自控镇痛给药方案。210名年龄在18岁到65岁之间的ED患者需要静脉注射阿片类止痛药，他们将参加一项随机、双盲、安慰剂对照研究。所有患者将接受负荷量的吗啡0.1毫克/公斤。然后他们将获得：1.0毫克、1.5毫克吗啡或安慰剂PCA按需剂量，每6分钟可用。在首次注射吗啡后，每半小时至2小时记录一次数字分级量表，以衡量疼痛强度。学习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需要由临床工作人员酌情给予吗啡补充。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。在进行差异分析后，将在两组之间进行预先计划的比较。如果出现基线差异，将使用多元统计对其进行调整。次要终点是总共两个小时的观察期内的疼痛、临床工作人员额外使用的镇痛剂的数量和剂量、恶心、呕吐和瘙痒的发生率。我们假设，与可由临床工作人员酌情补充的单次剂量相比，PCA将提供更好的止痛效果，而不良事件的发生率不会更高；而1.5 mg的需求剂量将优于1.0 mg，而不会出现更多的不良事件。PCA在ED中的应用构成了在这个具有挑战性的环境中改进疼痛管理的一种新的和有前途的方法。公共卫生相关性：这项研究旨在为急诊科患者自控镇痛治疗腹痛的安全性和有效性提供初步数据。它代表了一种在这个繁忙和苛刻的环境中管理疼痛的新方法。