Juhl Gitte I, Norholt Sven E, Tonnesen Else, Hiesse-Provost Odile, Jensen Troels S
Danish Pain Research Centre, Aarhus University Hospital, Denmark.
Eur J Pain. 2006 May;10(4):371-7. doi: 10.1016/j.ejpain.2005.06.004. Epub 2005 Aug 8.
The recommended dose for intravenous (IV) paracetamol injection in adults is 1g, however pharmacokinetic and pharmacodynamic findings suggest that a better analgesia could be obtained with a 2 g starting dose.
A single-centre, randomised, double-blind, placebo-controlled, 3-parallel group study was performed to demonstrate the analgesic efficacy and safety of IV paracetamol 2 g. Following third molar surgery, patients reporting moderate to severe pain received a single 15-min infusion of either IV paracetamol 2 g, IV paracetamol 1g or placebo. Efficacy and safety were evaluated over 8 h. Laboratory tests were performed before and 48 h after drug administration.
Two hundred and ninety seven patients (132 = IV paracetamol 2g; 132 = IV paracetamol 1g; 33 = placebo) were randomised and completed the study. The summed pain relief over 6h (TOTPAR6) was significantly superior with IV paracetamol 2 g as compared to IV paracetamol 1g and placebo (p < 0.0001). Pain relief scores of IV paracetamol 2g were significantly superior to IV paracetamol 1g and to placebo from T30' to T8h (p < 0.0001). Median duration of analgesia was significantly longer following IV paracetamol 2 g compared to IV paracetamol 1g and placebo (p < 0.0001). Adverse events occurred with the same frequency in the 3 treatment groups. No clinically significant changes from baseline were observed for vital signs or laboratory tests.
The analgesic efficacy of a 2 g starting dose of IV paracetamol was superior over the recommended dose of 1g in terms of magnitude and duration of analgesic effect for postoperative pain following third molar surgery, with no significant difference between groups regarding safety.
成人静脉注射扑热息痛的推荐剂量为1克，然而药代动力学和药效学研究结果表明，起始剂量为2克时镇痛效果更佳。
开展了一项单中心、随机、双盲、安慰剂对照的三平行组研究，以证明静脉注射2克扑热息痛的镇痛效果和安全性。在拔除第三磨牙手术后，报告有中度至重度疼痛的患者接受一次15分钟的静脉输注，输注药物为2克静脉注射扑热息痛、1克静脉注射扑热息痛或安慰剂。在8小时内评估疗效和安全性。在给药前和给药后48小时进行实验室检查。
297例患者（132例 = 2克静脉注射扑热息痛组；132例 = 1克静脉注射扑热息痛组；33例 = 安慰剂组）被随机分组并完成研究。与1克静脉注射扑热息痛和安慰剂相比，2克静脉注射扑热息痛组6小时内的总疼痛缓解程度（TOTPAR6）显著更高（p < 0.0001）。从30分钟到8小时，2克静脉注射扑热息痛组的疼痛缓解评分显著高于1克静脉注射扑热息痛组和安慰剂组（p < 0.0001）。与1克静脉注射扑热息痛和安慰剂相比，2克静脉注射扑热息痛后的中位镇痛持续时间显著更长（p < 0.0001）。三个治疗组中不良事件的发生频率相同。生命体征或实验室检查未观察到与基线相比有临床意义的变化。
对于第三磨牙手术后的疼痛，2克起始剂量的静脉注射扑热息痛在镇痛效果的强度和持续时间方面优于推荐剂量1克，且各组在安全性方面无显著差异。
