[Treating pain after dental surgery: a randomised, controlled, double-blind trial to assess a new formulation of paracetamol, opium powder and caffeine versus tramadol or placebo].
[Treating pain after dental surgery: a randomised, controlled, double-blind trial to assess a new formulation of paracetamol, opium powder and caffeine versus tramadol or placebo].
复制标题
DOI：
10.1016/j.lpm.2009.09.025
复制
发表时间：
2010-05-01
期刊：
影响因子：
--
通讯作者：
Dallel, Radhouane
中科院分区：
文献类型：
--
作者：
Borel, Jean-Francois;Deschaumes, Christophe;Dallel, Radhouane
背景技术背景：本研究的目的是评价对乙酰氨基酚、鸦片制剂和咖啡因联合给药与传统镇痛药盐酸曲马多相比对急性术后疼痛的镇痛效果和安全性。方法：我们进行了一项随机、双盲、多中心、平行组临床试验，以检验两种联合给药单次给药的有效性和安全性;对乙酰氨基酚500 mg、咖啡因50 mg、鸦片制剂25和对乙酰氨基酚500 mg、咖啡因50 mg、鸦片制剂50 mg，与盐酸曲马多100 mg（以下称为曲马多100）和安慰剂相比，用于控制拔除2颗同侧阻生第三磨牙后的术后疼痛。主要疗效标准为基线评估和研究治疗给药后3小时内每30分钟评估一次的疼痛强度差异之和（SPID（0- 3小时））。对主要疗效标准（SPID（0- 3 h））的分析确定：（i）3种活性研究治疗与安慰剂相比的优效性（p
BACKGROUND: The aim of this study was to evaluate the analgesic efficacy and the safety of the association, paracetamol, opium prepared and caffeine, in two different dosages as compared to the conventional analgesic tramadol hydrochloride, on acute postoperative dental pain.METHODS: We conducted a randomised, double-blind, multicentre, parallel-group clinical trial to test the efficacy and safety of single doses of two associations; paracetamol 500 mg, caffeine 50mg, opium prepared 25, and paracetamol 500 mg, caffeine 50mg, opium prepared 50mg, as compared to tramadol hydrochloride 100mg (called hereafter tramadol 100), and placebo, in the control of postoperative pain following the removal of 2 ipsilateral impacted third molars. The primary efficacy criterion was the sum of pain intensity differences as assessed every 30 minutes within 3 hours after the baseline assessment and administration of study treatment (SPID(0-3h)).RESULTS: Of the 232 randomised patients, 228 (98%) completed the study. Analysis of the primary efficacy criterion (SPID(0-3h)) established: (i) the superiority of the 3 active study treatments vs. placebo (p