Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

急诊室患者自控镇痛的有效性和可行性

• 批准号: 8419588
• 负责人: Polly Ellen Bijur
• 金额: $ 42.52万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-27 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8419588
• 关键词: Abdominal Pain; Absence of pain sensation; Accident and Emergency department; Acute Pain; Address; Adverse event; Analgesics; Caring; Client satisfaction; Clinical; Clinical Trials Design; Devices; Discipline of Nursing; Dose; Effectiveness; Environment; Etiology; Evaluation; Funding; Goals; Hour; Hypotension; Incidence; Incidence Study; Individual; Infusion procedures; Intervention; Liquid substance; Maintenance; Measures; Medical; Methodology; Modeling; Morphine; Naloxone; Nurses; Nursing Research; Opioid; Opioid Analgesics; Oxygen; Pain; Pain Measurement; Pain intensity; Pain management; Participant; Patient-Controlled Analgesia; Patients; Pharmaceutical Preparations; Pharmacy facility; Physicians; Preparation; Protocols documentation; Provider; Randomized; Randomized Clinical Trials; Research; Resources; Safety; Site; Supplementation; Time; Titrations; Training; Vasoconstrictor Agents; arm; clinical care; comparative effectiveness; compare effectiveness; cost; experience; improved; innovation; novel; nursing standards; primary outcome; satisfaction; secondary outcome

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. PUBLIC HEALTH RELEVANCE: Optimal Emergency Department (ED) pain management is a major nursing and medical challenge. Patient-controlled analgesia has great potential to address this problem if effectiveness and feasibility of application to the ED setting are demonstrated in this study.

描述（由申请人提供）：急诊科（艾德）疼痛管理不足已得到充分记录。疼痛的最佳治疗需要频繁的疼痛评估和阿片类药物滴定至有效剂量，因为个体间的需求差异很大。然而，由于患者与护士和医生的比例较高以及患者的多种紧急需求，在这种情况下难以提供滴定。病人自控镇痛（PCA）有可能让艾德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NINR资助的随机临床试验（RCT）为PCA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，该试验在一个艾德，由一名专门的研究护士和所有患者给予标准负荷剂量。目的：评估PCA改善艾德疼痛管理的能力具体目的：1）比较PCA和非PCA阿片类镇痛的有效性和安全性，当参与临床护理的护士在多个研究中心对一组广泛的急性疼痛艾德患者进行干预时。主要假设是，随着时间的推移，疼痛会有更大的下降，并且随机分配至 与接受标准阿片类镇痛的患者相比，2)描述PCA在患者和提供者接受度、资源利用率以及与实施和使用相关的成本方面的可行性。创新：PCA代表了一种新的转变，从目前的供应商驱动的模式艾德疼痛管理的病人是一个积极的参与者。以前很少有研究评价了艾德PCA，也没有系统的时间和资源评价。方法：将在3个临床中心进行RCT。将750例急性疼痛缓解IV阿片类药物给药的患者随机接受由提供者或PCA确定的常规阿片类药物镇痛（负荷剂量0.1 mg/kg吗啡和需求剂量1 mg吗啡，每6分钟一次）。在首次阿片类药物给药后，将通过每半小时记录一次的数字评定量表测量疼痛强度，最长2小时。主要终点是首次给药后30分钟疼痛强度的变化率 根据初步研究结果和不良事件发生率的建议，阿片类药物可持续2小时。还将在2小时研究期结束时，通过患者对疼痛管理的满意度、RN对时间效率/易用性和疼痛管理满意度的评估以及医生对疼痛管理的满意度，将PCA与非PCA阿片类镇痛进行比较。将通过RN在每位患者疼痛管理上花费的总时间、每位患者的药房准备时间、每位患者的材料成本以及RN和MD实施PCA所需的培训时间，评估与在艾德环境中实施和使用PCA相关的资源利用和成本。重要性：如果PCA被证明是有效的，安全的，并与患者和供应商的接受和可接受的资源利用率，它有可能显着改善艾德疼痛管理。 公共卫生相关性：最佳急诊科（艾德）疼痛管理是一个主要的护理和医疗挑战。如果在本研究中证明了应用于艾德环境的有效性和可行性，患者自控镇痛具有很大的潜力来解决这个问题。