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

基本信息

批准号：
8554376
负责人：
Polly Ellen Bijur
金额：
$ 42.93万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
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/8554376
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 public health relevance satisfaction secondary outcome

项目摘要

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.

描述（由申请人提供）：急诊室 (ED) 疼痛管理不足是有据可查的。由于个体间需求差异较大，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。然而，由于患者与护士和医生的比例较高以及多个紧急的患者竞争需求，在这种情况下很难提供滴定。患者自控镇痛 (PCA) 有可能使 ED 患者通过自我滴定至所需的疼痛缓解水平来积极参与疼痛管理。我们小组最近完成的一项 NINR 资助的随机临床试验 (RCT) 为 PCA 在单一急诊室治疗腹痛患者的有效性和安全性提供了有前景的初步支持，并配备了专门的研究护士并向所有患者提供标准负荷剂量。目的：评估 PCA 改善 ED 疼痛管理的能力具体目标：1) 比较 PCA 和非 PCA 阿片类药物镇痛的有效性和安全性，当参与临床护理的护士向广泛的急性 ED 患者提供干预时多个研究部位的疼痛。主要假设是，随着时间的推移，随机分组的患者的疼痛会明显减轻，并且安全性相似接受 PCA 的患者与接受标准阿片类镇痛的患者进行比较。 2) 描述 PCA 在患者和提供者接受度、资源利用以及与实施和使用相关的成本方面的可行性。创新：PCA 代表了一种新颖的转变，从当前由医疗服务提供者驱动的 ED 疼痛管理模式向患者积极参与的模式转变。之前很少有研究评估 ED PCA，并且不存在对时间和资源的系统评估。方法：随机对照试验将在 3 个临床中心进行。 750 名需要静脉注射阿片类药物的急性疼痛患者将被随机分配接受由提供者或 PCA 确定的常规阿片类镇痛药物（负荷剂量 0.1 mg/kg 吗啡，需求剂量为每 6 分钟 1 mg 吗啡）。疼痛强度将通过初始阿片类药物给药后每半小时至 2 小时记录的数字评定量表进行测量。主要终点是初次给药后 30 分钟后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，阿片类药物的服用时间为 2 小时。还将在 2 小时研究期结束时根据患者对疼痛管理的满意度进行评估，将 PCA 与非 PCA 阿片类镇痛进行比较； RN 评估时间效率/易用性以及对疼痛管理的满意度；以及医生对疼痛管理的满意度。与在急诊室实施和使用 PCA 相关的资源利用率和成本将根据每位患者在疼痛管理上花费的注册护士总时间进行评估；每个患者的药房准备时间；每个患者的材料成本以及实施 PCA 所需的 RN 和 MD 培训时间。意义：如果 PCA 被证明是有效、安全的，并且与患者和提供者的接受度以及可接受的资源利用相关，那么它有可能显着改善 ED 疼痛管理。