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：
8688815
负责人：
Polly Ellen Bijur
金额：
$ 12.37万
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 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8688815
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 Emergency Department patient 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）：急诊科（ED）疼痛管理已有据可查。疼痛的最佳治疗需要经常进行疼痛评估和阿片类药物滴定，以进行有效剂量，这是由于需求的较大间隔可变性。但是，由于高患者对护士和生理比率以及多个紧急竞争患者的需求，因此在这种情况下很难提供滴定。患者控制的镇痛（PCA）有可能使ED患者通过允许自给自期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）提供了有希望的初步支持，以对PCA的疗效和安全性在单个ED的患者中具有专门的研究护士和给所有患者的标准负荷剂量的单一ED患者。目的：评估PCA改善ED疼痛管理的特定目的的能力：1）当参与临床护理的护士将干预措施提供给多个研究部位的急性疼痛患者时，比较PCA和非PCA阿片类镇痛的有效性和安全性。主要的假设是，随着时间的流逝，疼痛的下降将会更大，患者的安全性相似与接受标准阿片类镇痛的患者相比，接受PCA。 2）描述PCA在患者和提供者的接受，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代表了从当前以提供商驱动的ED疼痛管理模型到患者为活跃参与者的新型转变。很少有研究评估了ED PCA，并且没有对时间和资源的系统评估。方法：将在3个临床中心进行RCT。 750例急性疼痛的患者必须随机分配静脉注射阿片类药物，以接受由提供者或PCA确定的常规阿片类镇痛作用（加载剂量0.1 mg/kg吗啡，并且每6分钟可用1 mg吗啡的需求剂量）。疼痛强度将通过在初次阿片类药物给药后每半小时记录每半小时记录的数值评分量表来衡量。主要终点是疼痛强度的变化率，从初始给药后30分钟起如初步研究和不良事件发生率的结果所建议的那样，阿片类药物为2小时。还将通过患者对疼痛管理的满意度进行比较，将PCA与在2小时研究期结束时评估的非PCA阿片类镇痛作用； RN评估时间效率/易用性和对疼痛管理的满意度；以及医师对疼痛管理的满意度。在ED设置中，与PCA实施和使用相关的资源利用和成本将通过每位患者疼痛管理花费的总时间来评估；每位患者的药房准备时间； PCA实施所需的每位患者的材料成本以及RN和MD培训时间。意义：如果证明PCA有效，安全并且与患者和提供者的接受以及可接受的资源利用相关，则它有可能显着改善ED疼痛管理。