Moller Philip Lange, Juhl Gitte Irene, Payen-Champenois Catherine, Skoglund Lasse Ansgar
Department of Anesthesia, University Hospital of Aarhus, Norrebrogade 44, DK-8000 Aarhus, Denmark.
Anesth Analg. 2005 Jul;101(1):90-6, table of contents. doi: 10.1213/01.ANE.0000155297.47955.D6.
We compared an acetaminophen (paracetamol) 1 g (n = 51) formulation for infusion with propacetamol 2 g (n = 51) and placebo (n = 50) in a randomized, controlled, double-blind, parallel group trial in patients with moderate-to-severe pain after third molar surgery. Treatment efficacy was assessed in house for 6 h after starting the 15-min infusion. Significant effects versus placebo (P < 0.01) were obtained with both active treatments on pain relief, pain intensity difference on a 100-mm visual analog scale, and on a categorical scale (except for propacetamol at 6 h). No significant differences were noted between active groups except at 1 h. Six-hour weighted sums of primary assessments showed significantly better efficacy than placebo (P < 0.0001) and no difference between active treatments. Median stopwatch time to onset of pain relief for active treatment was 6-8 min after infusion start. Active treatments showed comparable efficacy with a significantly longer duration of analgesia and better patients' global evaluation compared with placebo. The incidence of patients reporting local pain at the infusion site was significantly less frequent after IV acetaminophen or placebo (0%) in comparison with propacetamol (49%). In conclusion, acetaminophen 1 g and propacetamol 2 g were superior to placebo regarding analgesic efficacy, with a more frequent incidence of local pain at the infusion site for propacetamol.
在一项针对拔除第三磨牙后中重度疼痛患者的随机、对照、双盲、平行组试验中,我们将1克对乙酰氨基酚(扑热息痛)静脉输注制剂(n = 51)与2克丙帕他莫(n = 51)及安慰剂(n = 50)进行了比较。在开始15分钟输注后的6小时内对治疗效果进行了内部评估。两种活性治疗在缓解疼痛、100毫米视觉模拟量表上的疼痛强度差异以及分类量表上(6小时时的丙帕他莫除外)均与安慰剂相比有显著效果(P < 0.01)。除1小时外,活性组之间未观察到显著差异。主要评估的6小时加权总和显示,与安慰剂相比疗效显著更好(P < 0.0001),活性治疗之间无差异。活性治疗开始输注后疼痛缓解的中位秒表时间为6 - 8分钟。与安慰剂相比,活性治疗显示出相当的疗效,镇痛持续时间显著更长,患者总体评价更好。与丙帕他莫(49%)相比,静脉注射对乙酰氨基酚或安慰剂后报告输注部位局部疼痛的患者发生率显著更低(0%)。总之,1克对乙酰氨基酚和2克丙帕他莫在镇痛效果上优于安慰剂,丙帕他莫输注部位局部疼痛的发生率更高。