Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

急诊科患者自控镇痛的安全性和有效性

• 批准号: 7511959
• 负责人: Polly Ellen Bijur
• 金额: $ 31.81万
• 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 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7511959
• 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; End Point; Enrollment; Ensure; Environment; Foundations; Future; Goals; Hour; Incidence; Individual; Infusion Pumps; Intravenous; Measures; Medical; Monitor; Morphine; Nausea and Vomiting; Numbers; Nurses; Opioid; Opioid Analgesics; Oxygen; Pain; Pain management; Patient-Controlled Analgesia; Patients; Personal Satisfaction; Pharmaceutical Preparations; Physicians; Placebos; Postoperative Pain; Postoperative Period; Provider; Pruritus; Public Health; Random Allocation; Randomized; Rate; Research; Resources; Safety; Standards of Weights and Measures; Supplementation; Time; Titrations; Toxic effect; Treatment Protocols; Upper arm; desire; improved; novel; novel strategies; placebo controlled study; respiratory; 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（由申请人提供）：急诊科（ED）的疼痛管理是一个主要的护理和医疗挑战。 ED疼痛管理不足已得到充分记录。阿片类镇痛药构成了急性疼痛的标准治疗方法，但是在ED中最佳使用阿片类药物存在许多障碍。这些障碍包括较高的患者比率，急性病患者的同时需求，阿片类药物需求的较大差异，相关剂量相关的毒性以及缺乏提供个性化疼痛管理的资源。患者控制的镇痛（PCA）已成功用于术后疼痛管理。在这种情况下，患者通常会接受吗啡的滴定，直到患者舒适，然后开始PCA。鉴于在ED中提供了这种密集管理的障碍，PCA有可能通过允许对所有患者进行初始大通剂量的阿片类药物来改善疼痛管理，然后再对患者发起的需求给药。该方案是一种新颖的手段，可以弥合从初始剂量不足的疼痛缓解疼痛之间的差距，并且镇痛较高的患者期望这种疼痛。它也可用于维持ED停留的患者随着时间的流逝而保持镇痛。 PCA在ED中的应用最少。很少有研究严格评估其对功效和安全性的影响。该研究的目的是：1）评估ED中PCA的功效和安全性； 2）比较两种PCA剂量方案。 210名年龄在18至65岁的ED患者患有腹痛需要静脉注射阿片类镇痛药，将纳入一项随机的双盲安慰剂对照研究。所有患者的负荷剂量均为0.1 mg/kg吗啡。然后，他们将收到：1.0毫克，1.5毫克吗啡或安慰剂PCA需求每6分钟可用剂量。初始给药后，每半小时记录每半小时每半小时记录的数值评分量表将用于测量疼痛强度。研究护士将连续监测氧饱和度，呼吸率和收缩压。所有患者都可以根据临床人员酌情根据需要接受吗啡补充。主要终点是从基线到30分钟的疼痛强度的变化以及不良事件的发生率。分析方差分析后，将进行两组之间的预计划比较。如果发生多元统计，则将用于调整基线差异。次要终点是在整个两个小时观察期间的疼痛，临床人员进行的其他镇痛药的数量和剂量，恶心，呕吐和瘙痒症的发生率。我们假设PCA将提供出色的镇痛作用，而没有更大的不良事件发生率，而不是单剂量可以由临床人员酌情补充的单剂量。并且这种需求剂量为1.5毫克，而没有更多不利事件的剂量将优于1.0 mg。 PCA在ED上的应用构成了一种新颖而有前途的方法来改善这种挑战性的环境。公共卫生相关性：本研究旨在提供有关患者控制镇痛治疗腹痛的安全性和有效性的初步数据。它代表了在这种繁忙且苛刻的环境中管理疼痛的一种新颖方法。