Thienthong Somboon, Krisanaprakornkit Wimonrat, Taesiri Worranut, Thaninsurat Nuanchan, Utsahapanich Siriporn, Klaichanad Chongsuk
Department of Anesthesiology, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.
J Med Assoc Thai. 2004 Jan;87(1):24-32.
BACKGROUND: Tramadol is a weak opioid agonist with antinociceptive effects through its action on the mu-receptor and by inhibiting the neuronal re-uptake of both noradrenaline and serotonin. Tramadol is commonly used for treatment of mild to moderate post-operative pain. An oral form of sustained-release tramadol (SR) was recently formulated for reducing the administration frequency from qid to bid. OBJECTIVE: To evaluate the analgesic efficacy and safety of two doses of oral tramadol SR for the treatment of pain after modified radical mastectomy. STUDY DESIGN: Randomized, double blind, placebo-controlled trial. METHOD: Fifty women were randomly allocated to receive either tramadol SR 100 mg (group T), or placebo tablet (group P) orally approximately 1 hour before surgery with a repeat dose administered 12 hours later by nurses not apprised of the patient groupings. All patients received the standard general anesthesia. Post-operatively, nurses in the research team assessed pain using a visual analog scale 0-100 mm at rest (rVAS) and during arm movements (mVAS) at admission to postanesthesia care unit (PACU) (T0) and 2 (T2), 6 (T6), 12 (T12) and 24 (T24) hours after surgery. Rescue analgesia was provided for 24 hours via a morphine-loaded patient-controlled analgesia (PCA) device at 1 mg bolus with a 5-minute lockout interval. Cumulative morphine consumption and adverse events were recorded. RESULTS: Twenty-five patients with comparable baseline characteristics from each group were studied. The proportions of patients with VAS > 30 (both rVAS and mVAS) at each measurement period were not significantly different between the groups except for the mVAS at T24, where the proportion in group T was higher than group P (48% vs 20%, 95% CI of difference: -53%, -3%, p = 0.04). The median morphine consumption in both groups at T2, T6, T12 and T24 were comparable. No serious adverse effects were observed; however, patients in group T reported nausea and vomiting more than group P (56% vs 24%, p = 0.02). CONCLUSION: Two doses of oral tramadol SR 100 mg had no effect on post-operative pain scores and morphine consumption in patients who underwent modified radical mastectomy. In fact, more patients in the tramadol group reported nausea and vomiting than the placebo group.
背景：曲马多是一种弱阿片类激动剂，通过作用于μ受体以及抑制去甲肾上腺素和5-羟色胺的神经元再摄取发挥镇痛作用。曲马多常用于治疗轻至中度术后疼痛。一种口服缓释曲马多（SR）剂型最近被研制出来，用于将给药频率从每日4次减至每日2次。 目的：评估两种剂量的口服缓释曲马多治疗改良根治性乳房切除术后疼痛的镇痛效果和安全性。 研究设计：随机、双盲、安慰剂对照试验。 方法：50名女性被随机分配，在手术前约1小时口服100mg缓释曲马多（T组）或安慰剂片（P组），12小时后由不了解患者分组情况的护士给予重复剂量。所有患者均接受标准全身麻醉。术后，研究团队的护士在患者进入麻醉后护理单元（PACU）时（T0）以及术后2（T2）、6（T6）、12（T12）和24（T24）小时，使用0 - 100mm视觉模拟量表评估静息时（rVAS）和手臂运动时（mVAS）的疼痛程度。通过装有吗啡的患者自控镇痛（PCA）装置在24小时内提供解救镇痛，单次推注剂量为1mg，锁定时间间隔为5分钟。记录吗啡累积用量和不良事件。 结果：每组研究25例基线特征可比的患者。除了T24时的mVAS，各测量期VAS>30（rVAS和mVAS）的患者比例在两组间无显著差异，T24时T组的比例高于P组（48%对20%，差异的95%CI：-53%，-3%，p = 0.04）。两组在T2、T6、T12和T24时的吗啡用量中位数相当。未观察到严重不良反应；然而，T组患者报告恶心和呕吐的比例高于P组（56%对24%，p = 0.0
J Cardiothorac Vasc Anesth. 2005-8
Acta Anaesthesiol Scand. 2007-5
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