DeAndrade J R, Maslanka M, Reines H D, Howe D, Rasmussen G L, Cardea J, Brown J, Bynum L, Shefrin A, Chang Y L, Maneatis T
Department of Orthopaedic Surgery, Emory University Clinic, Atlanta, GA, USA.
Clin Orthop Relat Res. 1996 Apr(325):301-12.
In this double-blind, randomized, multicenter study, 244 patients with at least moderate pain after major orthopaedic surgery received intramuscular Ketorolac (60 mg followed by 30 mg) or intramuscular meperidine (100 mg or placebo) every 2 to 6 hours as needed for as many as 5 days. Analgesic response was evaluated for 6 hours after initial study drug administration and thereafter each night at bedtime. Both active treatment groups had similar 3-hour summed pain intensity difference and 3-hour total pain relief scores after the first dose that were superior to placebo. The 6-hour summed pain intensity difference and total pain relief scores were significantly higher with Ketorolac than with meperidine or placebo. The mean daily categorical pain intensity scores were comparable with Ketorolac and meperidine, and both were significantly superior to placebo. Patient ratings of overall medication efficacy were significantly better with Ketorolac than with meperidine. In both patient and observer evaluations, Ketorolac was significantly better tolerated than meperidine, and the number of patients reporting adverse events was lower with Ketorolac than with meperidine. Following major orthopaedic surgery, Ketorolac provided effective analgesia that was superior to placebo and at least comparable with meperidine. Ketorolac was better tolerated than meperidine.
在这项双盲、随机、多中心研究中,244例接受大型骨科手术后至少有中度疼痛的患者,根据需要每2至6小时接受一次肌肉注射酮咯酸(先60毫克,后30毫克)或肌肉注射哌替啶(100毫克或安慰剂),持续多达5天。在首次给予研究药物后6小时以及此后每晚就寝时评估镇痛反应。两个活性治疗组在首次给药后的3小时累计疼痛强度差值和3小时总疼痛缓解评分相似,均优于安慰剂。酮咯酸组的6小时累计疼痛强度差值和总疼痛缓解评分显著高于哌替啶组或安慰剂组。酮咯酸组和哌替啶组的每日平均分类疼痛强度评分相当,且均显著优于安慰剂。患者对总体药物疗效的评分,酮咯酸组显著优于哌替啶组。在患者和观察者评估中,酮咯酸的耐受性均显著优于哌替啶,且报告不良事件的患者数量酮咯酸组少于哌替啶组。大型骨科手术后,酮咯酸提供了优于安慰剂且至少与哌替啶相当的有效镇痛作用。酮咯酸的耐受性优于哌替啶。