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
基本信息
- 批准号:7511959
- 负责人:
- 金额:$ 31.81万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Abdominal PainAbsence of pain sensationAccident and Emergency departmentAcute PainAdverse eventAgeAnalgesicsAnalysis of VarianceBlood PressureBolus InfusionClinicalCrowdingDataDiscipline of NursingDoseDouble-Blind MethodEnd PointEnrollmentEnsureEnvironmentFoundationsFutureGoalsHourIncidenceIndividualInfusion PumpsIntravenousMeasuresMedicalMonitorMorphineNausea and VomitingNumbersNursesOpioidOpioid AnalgesicsOxygenPainPain managementPatient-Controlled AnalgesiaPatientsPersonal SatisfactionPharmaceutical PreparationsPhysiciansPlacebosPostoperative PainPostoperative PeriodProviderPruritusPublic HealthRandom AllocationRandomizedRateResearchResourcesSafetyStandards of Weights and MeasuresSupplementationTimeTitrationsToxic effectTreatment ProtocolsUpper armdesireimprovednovelnovel strategiesplacebo controlled studyrespiratorystatistics
项目摘要
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) 的疼痛管理是一项重大的护理和医疗挑战。急诊科疼痛管理不足已有充分记录。阿片类镇痛药是急性疼痛的标准治疗方法,但在急诊科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比例高、急症患者的同时需求、阿片类药物需求的个体间差异大、剂量相关的毒性以及缺乏提供个体化疼痛管理的资源。患者自控镇痛(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滴定直至患者感到舒适,然后开始 PCA。考虑到在急诊室提供这种强化管理的障碍,PCA 有可能通过允许向所有患者给予初始推注剂量的阿片类药物,然后根据患者的需求给药,从而改善疼痛管理。该方案是一种新颖的方法,可以弥补初始剂量通常不足的疼痛缓解与具有较高镇痛需求的患者所期望的疼痛缓解之间的差距。它还可用于对急诊科住院时间较长的患者维持镇痛。 PCA 在 ED 中的应用很少;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 PCA 在急诊室中的有效性和安全性; 2) 比较两种 PCA 给药方案。 210 名年龄在 18 岁至 65 岁之间、患有腹痛、需要静脉注射阿片类药物镇痛的 ED 患者将被纳入一项随机双盲安慰剂对照研究。所有患者将接受 0.1 mg/kg 吗啡的负荷剂量。然后,他们将接受: 1.0 毫克、1.5 毫克吗啡或安慰剂 PCA 按需给药,每 6 分钟一次。首次使用吗啡后,每半小时至 2 小时记录一次数字评定量表,用于测量疼痛强度。研究护士将持续监测氧饱和度、呼吸频率和收缩压。所有患者都可以根据临床工作人员的判断按需补充吗啡。主要终点是疼痛强度从基线到 30 分钟的变化以及不良事件的发生率。方差分析后将进行预先计划的组间比较。如果出现基线差异,将使用多变量统计数据进行调整。次要终点是整个两小时观察期内的疼痛、临床工作人员施用的额外镇痛药的数量和剂量、恶心、呕吐和瘙痒的发生率。我们假设 PCA 将提供优异的镇痛效果,且不良事件的发生率不会高于单剂量(可由临床工作人员酌情补充);并且 1.5 mg 的需求剂量将优于 1.0 mg,且不会产生更多不良事件。 PCA 在急诊科的应用构成了一种新颖且有前途的方法,可以在这种充满挑战的环境中改善疼痛管理。公共健康相关性:本研究旨在提供有关急诊科腹痛管理患者自控镇痛的安全性和有效性的初步数据。它代表了一种在这种繁忙和苛刻的环境中控制疼痛的新颖方法。
项目成果
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Polly Ellen Bijur其他文献
Polly Ellen Bijur的其他文献
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{{ truncateString('Polly Ellen Bijur', 18)}}的其他基金
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:
8554376 - 财政年份:2012
- 资助金额:
$ 31.81万 - 项目类别:
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:
8688815 - 财政年份:2012
- 资助金额:
$ 31.81万 - 项目类别:
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 - 财政年份:2012
- 资助金额:
$ 31.81万 - 项目类别:
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 - 财政年份:2008
- 资助金额:
$ 31.81万 - 项目类别:
Racial and Ethnic Disparities in Acute Pain Control
急性疼痛控制方面的种族和民族差异
- 批准号:
6912767 - 财政年份:2003
- 资助金额:
$ 31.81万 - 项目类别:
Racial and Ethnic Disparities in Acute Pain Control
急性疼痛控制方面的种族和民族差异
- 批准号:
6679851 - 财政年份:2003
- 资助金额:
$ 31.81万 - 项目类别:
Racial and Ethnic Disparities in Acute Pain Control
急性疼痛控制方面的种族和民族差异
- 批准号:
6769924 - 财政年份:2003
- 资助金额:
$ 31.81万 - 项目类别:
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