Hartrick Craig T, Bourne Michael H, Gargiulo Kathryn, Damaraju C V, Vallow Sue, Hewitt David J
Department of Anesthesiology, William Beaumont Hospital, Royal Oak, MI 48073, USA.
Reg Anesth Pain Med. 2006 Nov-Dec;31(6):546-54. doi: 10.1016/j.rapm.2006.08.011.
The fentanyl HCl iontophoretic transdermal system (ITS) has been demonstrated in clinical trials to be safe and effective for acute-pain management after several types of major surgery. The current study compared the efficacy, safety, and convenience of fentanyl ITS with morphine intravenous patient-controlled analgesia (IV PCA) for acute-pain management after unilateral total-hip replacement (THR).
In this multicenter (52 sites), randomized, open-label, active-controlled, phase IIIb study, patients (n = 799) received fentanyl ITS (40 mug fentanyl [10-minute infusion/lockout], up to 6 doses/h) or morphine IV PCA (1-mg morphine bolus [5-minute lockout], up to 10 mg/h) after unilateral THR. The primary efficacy measure was success ratings ("excellent" or "good") on the patient global assessment (PGA) of the method of pain control in the first 24 hours. Pain intensity and adverse events were also assessed.
The PGA success ratings (83.0% v 82.2%; difference = 0.9%; 95% CI: -4.4% to 6.1%) and the mean last pain-intensity scores (3.0 v 3.0; difference = 0.0; 95% CI: -0.33 to 0.33) in the first 24 hours were statistically equivalent between fentanyl ITS and morphine IV PCA groups, respectively. The incidence of adverse events was similar between the groups.
Results of this study demonstrate fentanyl ITS and a standard regimen of morphine IV PCA were comparable methods of pain control for management of acute postoperative pain after THR, on the basis of the PGA success ratings and pain intensity in the first 24 hours of treatment.
盐酸芬太尼离子导入透皮系统（ITS）在临床试验中已被证明对几种大手术后的急性疼痛管理是安全有效的。本研究比较了芬太尼ITS与吗啡静脉自控镇痛（IV PCA）在单侧全髋关节置换术（THR）后急性疼痛管理中的疗效、安全性和便利性。
在这项多中心（52个地点）、随机、开放标签、活性对照的IIIb期研究中，患者（n = 799）在单侧THR后接受芬太尼ITS（40μg芬太尼[10分钟输注/锁定]，每小时最多6剂）或吗啡IV PCA（1mg吗啡推注[5分钟锁定]，每小时最多10mg）。主要疗效指标是治疗后前24小时患者对疼痛控制方法的总体评估（PGA）中的成功评分（“优秀”或“良好”）。还评估了疼痛强度和不良事件。
芬太尼ITS组和吗啡IV PCA组在治疗后前24小时的PGA成功评分（83.0%对82.2%；差异 = 0.9%；95%CI：-4.4%至6.1%）和最后平均疼痛强度评分（3.0对3.0；差异 = 0.0；95%CI：-0.33至0.33）在统计学上分别相当。两组间不良事件的发生率相似。
本研究结果表明，基于治疗后前24小时的PGA成功评分和疼痛强度，芬太尼ITS和标准的吗啡IV PCA方案是THR后急性术后疼痛管理中可比的疼痛控制方法。
