Department of Anesthesiology, University of Antioquia, IPS Universitaria Ambulatory Surgical Unit, Medellin, Colombia.
Pain Pract. 2012 Feb;12(2):142-7. doi: 10.1111/j.1533-2500.2011.00463.x. Epub 2011 Apr 20.
The efficacy of non-narcotic analgesics is mostly supported by randomized, placebo-controlled trials with no comparison with ordinary practice. Additionally, systematic reviews of these placebo-controlled trials have failed to determine clinically meaningful dose-response effect.
In this double-blind, randomized trial, patients undergoing elective inguinal, umbilical or epigastric herniorrhaphy under general anesthesia were assigned to receive 15 mg/kg (D15 group) vs. 40 mg/kg (D40 group) of dipyrone intravenously during surgery. The primary outcome was the incidence of moderate to severe pain with movement during the recovery room phase. The secondary outcomes were morphine consumption, incidence of vomiting, and Ramsay score (sedation scale).
One hundred sixty-two patients were enrolled and analyzed for the primary and secondary outcomes. Relative to the D15 group, the D40 group showed a lower incidence of moderate to severe pain in the first 30 minutes (61% and 40%; P value < 0.05); lower cumulative morphine consumption during the recovery period (3.85 vs. 2.55 mg, P value < 0.006) as well as a lower incidence of vomiting (15.8% vs. 2.5%, P value < 0.005). In addition, more cases of sedation were recorded in the D15 group than in the D40 group (17 vs. 10 cases). There were no serious adverse effects attributed to dipyrone in either group.
This trial shows a dose-response effect of 40 mg/kg over 15 mg/kg of intravenous dipyrone based on better movement-induced pain control, lower morphine consumption and fewer opioid-related side effects.
非阿片类镇痛药的疗效主要基于随机、安慰剂对照试验,而这些试验与普通实践没有比较。此外,这些安慰剂对照试验的系统评价未能确定具有临床意义的剂量反应效应。
在这项双盲、随机试验中,全身麻醉下择期行腹股沟、脐疝或上腹部疝修补术的患者被分配接受 15 毫克/公斤(D15 组)或 40 毫克/公斤(D40 组)的静脉注射双氯芬酸。主要结局是恢复室期间运动时中度至重度疼痛的发生率。次要结局是吗啡消耗量、呕吐发生率和 Ramsay 评分(镇静评分)。
162 例患者入组并分析了主要和次要结局。与 D15 组相比,D40 组在 30 分钟内中度至重度疼痛的发生率较低(61%和 40%;P 值<0.05);恢复期累积吗啡消耗量较低(3.85 与 2.55 毫克,P 值<0.006)以及呕吐发生率较低(15.8%与 2.5%,P 值<0.005)。此外,D15 组镇静的病例比 D40 组多(17 与 10 例)。两组均未发生与双氯芬酸相关的严重不良事件。
本试验显示,静脉注射双氯芬酸 40 毫克/公斤的剂量反应优于 15 毫克/公斤,表现为更好的运动相关疼痛控制、较低的吗啡消耗量和较少的阿片类药物相关副作用。