Cepeda Maria Soledad, Carr Daniel B, Miranda Nelcy, Diaz Adriana, Silva Claudia, Morales Olga
Department of Anesthesia and Clinical Epidemiology Unit, San Ignacio Hospital, Javeriana University School of Medicine, Cra 7 #40-62, Bogota, Colombia.
Anesthesiology. 2005 Dec;103(6):1225-32. doi: 10.1097/00000542-200512000-00018.
Meta-analyses report similar numbers needed to treat for nonsteroidal antiinflammatory drugs (NSAIDs) and opioids. Differences in baseline pain intensity among the studies from which these numbers needed to treat were derived may have confounded the results. NSAIDs have an opioid-sparing effect, but the importance of this effect is unclear. Therefore, the authors sought to compare the proportions of subjects who obtain pain relief with ketorolac versus morphine after surgery and to determine whether the opioid-sparing effect of an NSAID reduces the magnitude of opioid side effects.
The study was a double-blind, randomized controlled trial. The authors randomly assigned 1,003 adult patients to receive 30 mg ketorolac or 0.1 mg/kg morphine intravenously. They calculated the proportion of subjects who achieved at least 50% reduction in pain intensity 30 min after analgesic administration. Further, so long as pain intensity 30 min after analgesic administration was 5 or more out of 10, patients received 2.5 mg morphine every 10 min until pain intensity was 4 or less out of 10. The authors assessed the presence of opioid-related side effects.
Five hundred patients received morphine and 503 received ketorolac. Fifty percent of patients in the morphine group achieved pain relief, compared with 31% in the ketorolac group (difference, 19%; 95% confidence interval, 13-25%). The ketorolac-morphine group required less morphine (difference, 6.5 mg; 95% confidence interval, -5.8 to -7.2) and had a lower incidence of side effects (difference, 11%; 95% confidence interval, 5-16%) than the morphine group.
Opioids are more efficacious analgesics than NSAIDs, although historic data for these two drugs yield similar numbers needed to treat. Adding NSAIDs to the opioid treatment reduces morphine requirements and opioid-related side effects in the early postoperative period.
荟萃分析报告显示,非甾体抗炎药(NSAIDs)和阿片类药物的治疗所需人数相似。得出这些治疗所需人数的研究中,基线疼痛强度的差异可能混淆了结果。NSAIDs具有阿片类药物节省效应,但其重要性尚不清楚。因此,作者试图比较手术后使用酮咯酸与吗啡获得疼痛缓解的受试者比例,并确定NSAIDs的阿片类药物节省效应是否能降低阿片类药物副作用的严重程度。
该研究为双盲随机对照试验。作者将1003例成年患者随机分为两组,分别静脉注射30mg酮咯酸或0.1mg/kg吗啡。他们计算了镇痛药物给药30分钟后疼痛强度至少降低50%的受试者比例。此外,只要镇痛药物给药30分钟后的疼痛强度为10分制中的5分或更高,患者每10分钟接受2.5mg吗啡,直至疼痛强度为10分制中的4分或更低。作者评估了阿片类药物相关副作用的存在情况。
500例患者接受吗啡治疗,503例接受酮咯酸治疗。吗啡组50%的患者实现了疼痛缓解,而酮咯酸组为31%(差异为19%;95%置信区间为13%-25%)。与吗啡组相比,酮咯酸-吗啡组所需吗啡较少(差异为6.5mg;95%置信区间为-5.8至-7.2),副作用发生率较低(差异为11%;95%置信区间为5%-16%)。
阿片类药物是比NSAIDs更有效的镇痛药,尽管这两种药物的历史数据显示治疗所需人数相似。在阿片类药物治疗中添加NSAIDs可减少术后早期吗啡的需求量和阿片类药物相关副作用。