Merle J C, Vandroux D, Odin I, Dupuis J L, Bougault A, Mehaddi Y, Nathan N
Département d'anesthésie-réanimation chirurgicale, CHU Dupuytren, 2, avenue Martin-Luther-King, 87042 Limoges cedex, France.
Ann Fr Anesth Reanim. 2005 Jan;24(1):13-8. doi: 10.1016/j.annfar.2004.11.008.
To evaluate the efficacy of continuous infusion of nefopam. Indeed this analgesic is commonly used by continuous infusion by many anaesthetists to reduce its adverse effects. However whether the analgesic effect of an intermittent administration of nefopam has been proven, the efficacy of continuous infusion has not been established.
Double-blind placebo controlled prospective randomised study.
Sixty patients ASA 1 to 3 undergoing planned urological surgery with laparotomy were included. At the end of surgery, bolus doses of placebo (Group 3) or nefopam 20 mg (Group 1 and 2) were administered to all the patients. Placebo (Group 3), nefopam 80 mg (Group 1) or 120 mg (Group 2) was thereafter continuously infused over 24 hours. All patients received additional analgesia with PCA morphine. We measured pain at rest and on cough with VAS. Adverse side effects such as nausea and vomiting, sedation and respiratory depression were evaluated. Mental performance was measured with mini mental status tests.
Patients were older in the placebo group by approximately six years but anesthetic and surgical variables were not different between groups. Pain at rest and on cough was not statistically different between groups. In the placebo group, the median (interquartile range) morphine consumption reached 29 mg (13-53) whereas in patients receiving 80 and 120 mg nefopam, it levelled to 44 mg (11-54) and 35 mg (9-82) respectively (p > 0.05). Patients needed morphine during the same time period whether they received nefopam or not. Patients suffering from adverse effects were similar between groups.
In this study, continuous administration of nefopam did not reduce morphine consumption nor ameliorate analgesia and thus may not be recommended in urological surgery. Nefopam pharmacokinetics when used with continuous infusion as well as surgery types and differences in age between groups may explain these results.
评估奈福泮持续输注的疗效。实际上,许多麻醉医生常用这种镇痛药持续输注以减少其不良反应。然而,尽管间断给药的镇痛效果已得到证实,但持续输注的疗效尚未确定。
双盲安慰剂对照前瞻性随机研究。
纳入60例拟行开腹泌尿外科手术的ASA 1至3级患者。手术结束时,所有患者均给予安慰剂(第3组)或20 mg奈福泮(第1组和第2组)的推注剂量。此后,安慰剂(第3组)、80 mg奈福泮(第1组)或120 mg奈福泮(第2组)持续输注24小时。所有患者均接受PCA吗啡追加镇痛。我们用视觉模拟评分法(VAS)测量静息和咳嗽时的疼痛程度。评估恶心、呕吐、镇静和呼吸抑制等不良反应。用简易精神状态测试评估精神表现。
安慰剂组患者年龄约大6岁,但各组间麻醉和手术变量无差异。各组静息和咳嗽时的疼痛无统计学差异。安慰剂组吗啡消耗量中位数(四分位间距)达29 mg(13 - 53),而接受80 mg和120 mg奈福泮的患者分别降至44 mg(11 - 54)和35 mg(9 - 82)(p>0.05)。无论是否接受奈福泮,患者在同一时间段都需要吗啡。各组间出现不良反应的患者相似。
在本研究中,持续给予奈福泮并未减少吗啡消耗量,也未改善镇痛效果,因此在泌尿外科手术中可能不推荐使用。奈福泮持续输注时的药代动力学以及手术类型和组间年龄差异可能解释了这些结果。