Department of Anesthesiology and Pain Therapy, Ruhrlandklinik, University of Essen, DE-45239 Essen, Germany.
Pharmacology. 2009;84(5):276-81. doi: 10.1159/000242998. Epub 2009 Oct 1.
To assess clinical equivalence of 20 mg controlled-release oxycodone (Oxygesic; Mundipharma, Limburg, Germany) and 200 mg controlled-release tramadol (Tramal long; Grunenthal, Aachen, Germany) on a 12-hour dosing schedule in a randomized, double-blinded study of 54 ASA I-III physical status (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer.
General anesthesia using remifentanil and propofol was performed for surgery. Patients were randomly allocated to 2 groups, receiving either 20 mg controlled-release oxycodone (Oxy group) or 200 mg controlled-release tramadol (Trama group) with the premedication (7.5 mg midazolam) and again 12 hours later. All patients had access to rescue medication (i.v. paracetamol). The primary variables for clinical equivalence were the differences between the mean values for pain scores at rest and pain scores on coughing over 24 hours after operation. The equivalence margin was determined as +/-10 on the visual analogue scale.
Fifty-four patients were enrolled. Regarding pain scores at rest, the 90% CI of the mean differences between the treatment groups over 24 hours after operation was found to be within the predefined equivalence margin [-4.5 to +1.7], and the CI values for pain scores on coughing [-6.2 to +1.7] were similar. Cumulative paracetamol given over the 24-hour observation period did not differ significantly between the Oxy group (1.32 +/-1.9 g) and the Trama group (1.61 +/- 1.1 g; p = 0.32). There were no significant differences between the treatment groups regarding adverse events such as nausea (p = 0.13), vomiting (p = 0.24) and itching (p = 0.77). Also, no differences were found concerning patient satisfaction scores (p = 0.8) or patients' general perception of postoperative pain management (p = 0.71).
20 mg controlled-release oxycodone is clinically equivalent to 200 mg controlled-release tramadol for postoperative analgesia after surgery for breast cancer.
评估 20 毫克控释羟考酮（奥克赛吉；Mundipharma，林堡，德国）和 200 毫克控释曲马多（曲马多长；Grunenthal，亚琛，德国）在接受乳腺癌手术的 54 名 ASA I-III 身体状况（美国麻醉师协会身体状况分类）患者中以 12 小时剂量方案的临床等效性。
使用瑞芬太尼和丙泊酚进行全身麻醉进行手术。患者随机分配到 2 组，分别接受 20 毫克控释羟考酮（Oxy 组）或 200 毫克控释曲马多（Trama 组），并在术前（7.5 毫克咪达唑仑）和 12 小时后再次给药。所有患者均可以使用解救药物（静脉注射扑热息痛）。临床等效性的主要变量是术后 24 小时内静息时疼痛评分和咳嗽时疼痛评分的平均值之间的差异。等价区间确定为视觉模拟量表上的 +/-10。
共纳入 54 例患者。关于静息时的疼痛评分，发现在术后 24 小时内治疗组之间的平均差异的 90%置信区间（CI）落在预定的等效区间内[-4.5 至+1.7]，并且咳嗽时疼痛评分的 CI 值[-6.2 至+1.7]也相似。在 24 小时观察期间给予的累积扑热息痛在 Oxy 组（1.32 +/-1.9 g）和 Trama 组（1.61 +/-1.1 g；p = 0.32）之间无显著差异。在恶心（p = 0.13）、呕吐（p = 0.24）和瘙痒（p = 0.77）等不良事件方面，治疗组之间无显著差异。此外，在患者满意度评分（p = 0.8）或患者对术后疼痛管理的总体感知（p = 0.71）方面也未发现差异。
在乳腺癌手术后，20 毫克控释羟考酮与 200 毫克控释曲马多在术后镇痛方面具有临床等效性。
