NONPHARMACOLOGIC ANALGESIA FOR INVASIVE PROCEDURES

描述（改编自申请人摘要）：镇痛药 用于在微创外科手术过程中控制疼痛 效果有限，副作用严重，成本高。的 这项研究的长期目标是提供一种具有成本效益和安全的 行为方法减少疼痛和静脉注射药物的使用， 程序.一般来说，这些手术的镇痛依赖于 麻醉剂和镇静剂的静脉清醒镇静。外推 静脉清醒镇静的风险，以程序的数量，我们 预计每年有47，000名患者患有严重的心肺功能障碍， 并发症和2,600例死亡。 我们建议非药物镇痛的安全管理急性 程序性疼痛非药物镇痛包括放松训练， 自我催眠，以及由操作团队的一名成员应用的引导图像。 具体目标是：（1）前瞻性地确定 非药物镇痛对微创手术中疼痛和药物使用的影响 程序，（2）评估非药物镇痛对 微创手术的安全性，以及（3）确定 非药物镇痛对资源利用的影响。我们假设 非药物镇痛减少了疼痛和对静脉药物的需求 在微创手术过程中，提高了手术安全性， 与传统静脉镇痛相比， 完成后，围手术期非药物给药 镇痛将通过320年的严格和实际评估进行验证 患者非药物镇痛的相对性能将是 与井中的标准护理和移情注意力控制相比， 在受控的监测环境下， 忙碌的介入放射学实践。非药物整合 将镇痛纳入急性疼痛的主流治疗， 设计更大规模研究以确定临床效用的基础 多中心随机试验。

DESCRIPTION (Adapted from the Applicant s Abstract): Analgesics administered to control pain during minimally invasive surgical procedures have limited effectiveness, serious side effects, and high cost. The long-term objective of this research is to provide a cost-effective and safe behavioral method for reducing pain and intravenous drug use during invasive procedures. Analgesia for these procedures, in general, relies on intravenous conscious sedation with narcotics and sedatives. Extrapolating the risk of intravenous conscious sedation to the number of procedures, we predict annually 47,000 patients to suffer serious cardiorespiratory complication and 2,600 deaths. We propose nonpharmacologic analgesia for safe management of acute procedural pain. Nonpharmacologic analgesia includes relaxation training, self-hypnosis, and guided imagery applied by a member of the operating team. The specific aims are: (1) prospectively determine the effect of nonpharmacologic analgesia on pain and drug use during minimally invasive procedures, (2) assess the effect of nonpharmacologic analgesia on the safety of minimally invasive procedures, and (3) determine the effect of nonpharmacologic analgesia on resource utilization. We hypothesize that nonpharmacologic analgesia reduces pain and need for intravenous drugs during minimally invasive procedures, improves procedure safety, and reduces resource requirements compared with conventional intravenous analgesia. On completion, the periprocedural administration of nonpharmacologic analgesia will be validated by a rigorous and practical assessment in 320 patients. The relative performance of nonpharmacologic analgesia will be compared to a standard of care and empathic attention control in a well characterized population under the controlled monitored environment of a busy interventional radiology practice. Integration of nonpharmacologic analgesia into mainstream management of acute pain will be done to provide the basis for design of a larger study to determine clinical utility in a multicenter randomized trial.