The efficacy and safety of ketorolac for postoperative pain management in lumbar spine surgery: a meta-analysis of randomized controlled trials.

IF 6.3 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Systematic Reviews Pub Date : 2024-11-05 DOI:10.1186/s13643-024-02685-z
Jianbin Guan, Ningning Feng, Kaitan Yang, Haimiti Abudouaini, Peng Liu
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However, the effects and safety profile of ketorolac in these contexts remain controversial.</p><p><strong>Objective: </strong>We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of Ketorolac administration, both as a monotherapy and in combination with other analgesics, for managing postoperative pain in adults undergoing lumbar spinal surgery.</p><p><strong>Methods: </strong>We searched PubMed, EMbase, Web of Science, EBSCO, CNKI, WanFang, VIP, and Cochrane library databases through July 2024 for randomized controlled trials (RCTs) assessing the analgesic efficacy of Ketorolac administration for postoperative pain of lumbar surgery. The meta-analysis was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statements. 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During the 6-12-h period, the pain reduction was significant (MD =  - 0.58; 95% CI: - 0.80 to - 0.35; P < 0.0001), though below the MCID threshold. In the 12-24-h period, Ketorolac continued to show significant pain reduction (MD =  - 0.48; 95% CI: - 0.68 to - 0.28; P < 0.0001), but this reduction was also below the MCID. Heterogeneity was low in the 12-24-h period (I<sup>2</sup> = 13%), indicating consistent results across studies. There was a significant reduction in PMR (SMD =  - 1.83; 95% CI =  - 3.42 to - 0.23; P < 0.0001), although with considerable heterogeneity among the studies (I<sup>2</sup> = 93%, heterogeneity P < 0.01). Ketorolac administration also significantly reduced the LOS compared to controls (MD =  - 0.45 days; 95% CI =  - 0.74 to - 0.16; P = 0.0001), though this reduction, which is less than a full day (0.45 days), may have limited clinical significance. 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However, the variability in study designs, dosages, and combination therapies contribute to significant heterogeneity in outcomes. Future research should focus on standardizing protocols and exploring optimal dosing strategies. 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Abstract

Background: Ketorolac is widely utilized for postoperative pain management, including back pain after lumbar spinal surgery. Several trials have assessed the efficacy of Ketorolac alone and in combination with other analgesics such as bupivacaine, morphine, epinephrine, paracetamol, and pregabalin. However, the effects and safety profile of ketorolac in these contexts remain controversial.

Objective: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of Ketorolac administration, both as a monotherapy and in combination with other analgesics, for managing postoperative pain in adults undergoing lumbar spinal surgery.

Methods: We searched PubMed, EMbase, Web of Science, EBSCO, CNKI, WanFang, VIP, and Cochrane library databases through July 2024 for randomized controlled trials (RCTs) assessing the analgesic efficacy of Ketorolac administration for postoperative pain of lumbar surgery. The meta-analysis was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statements. Data were extracted and analyzed using open-source meta-analysis software OpenMeta-Analyst, focusing on outcomes such as VAS pain scores, postoperative morphine requirements (PMR), length of hospital stay (LOS), and adverse effects, such as nausea, vomiting, pruritus, and constipation. The quality of evidence was assessed using the Jada scale.

Results: Thirteen RCTs comprising a total of 938 patients were included. The methodological quality of the studies was high, with three studies scoring 5, six studies scoring 4, and four studies scoring 3 on the Jadad scale. Ketorolac significantly reduced pain compared to controls at 0-6 h, with a mean difference (MD) of - 1.42 (95% CI: - 2.03 to - 0.80; P < 0.0001), exceeding the Minimal Clinically Important Difference (MCID) of 1.2 to 2.0 points on the Visual Analog Scale (VAS), indicating clinically meaningful pain relief. During the 6-12-h period, the pain reduction was significant (MD =  - 0.58; 95% CI: - 0.80 to - 0.35; P < 0.0001), though below the MCID threshold. In the 12-24-h period, Ketorolac continued to show significant pain reduction (MD =  - 0.48; 95% CI: - 0.68 to - 0.28; P < 0.0001), but this reduction was also below the MCID. Heterogeneity was low in the 12-24-h period (I2 = 13%), indicating consistent results across studies. There was a significant reduction in PMR (SMD =  - 1.83; 95% CI =  - 3.42 to - 0.23; P < 0.0001), although with considerable heterogeneity among the studies (I2 = 93%, heterogeneity P < 0.01). Ketorolac administration also significantly reduced the LOS compared to controls (MD =  - 0.45 days; 95% CI =  - 0.74 to - 0.16; P = 0.0001), though this reduction, which is less than a full day (0.45 days), may have limited clinical significance. The findings suggest that Ketorolac effectively reduces pain and opioid use postoperatively, supporting its role in multimodal analgesia for lumbar spinal surgery. The significant reduction in PMR indicates a beneficial opioid-sparing effect, crucial in the context of reducing opioid-related complications. The observed reduction in LOS, while statistically significant, may not translate into substantial clinical benefit due to its limited magnitude. No significant increase in common adverse effects was noted, indicating Ketorolac's safety profile.

Conclusion: Ketorolac administration, either alone or in combination with other analgesics, effectively reduces postoperative pain and opioid consumption in adults following lumbar spinal surgery. And Ketorolac did not significantly increase the incidence of postoperative nausea and vomiting relative to other analgesics or placebos. While it also decreases LOS, the clinical relevance of this reduction is modest. However, the variability in study designs, dosages, and combination therapies contribute to significant heterogeneity in outcomes. Future research should focus on standardizing protocols and exploring optimal dosing strategies. Additionally, long-term safety and effectiveness studies are needed to better understand Ketorolac's role in postoperative pain management.

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酮咯酸治疗腰椎手术术后疼痛的有效性和安全性:随机对照试验荟萃分析。
背景:开托拉克被广泛用于术后疼痛治疗,包括腰椎手术后的背痛。多项试验评估了酮咯酸单独使用或与布比卡因、吗啡、肾上腺素、扑热息痛和普瑞巴林等其他镇痛药联合使用的疗效。然而,酮咯酸在这些情况下的效果和安全性仍存在争议:我们对随机对照试验(RCTs)进行了系统回顾和荟萃分析,以评估酮咯酸作为单药或与其他镇痛药联合应用治疗成人腰椎手术术后疼痛的有效性和安全性:截至 2024 年 7 月,我们在 PubMed、EMbase、Web of Science、EBSCO、CNKI、万方、VIP 和 Cochrane 图书馆数据库中检索了评估酮咯酸治疗腰椎手术术后疼痛的镇痛效果的随机对照试验 (RCT)。荟萃分析按照系统综述和荟萃分析首选报告项目(PRISMA)声明进行。使用开源荟萃分析软件 OpenMeta-Analyst 对数据进行提取和分析,重点关注 VAS 疼痛评分、术后吗啡需求量(PMR)、住院时间(LOS)以及恶心、呕吐、瘙痒和便秘等不良反应。证据质量采用 Jada 量表进行评估:结果:共纳入了 13 项 RCT 研究,包括 938 名患者。这些研究的方法学质量较高,其中 3 项研究的 Jadad 评分为 5 分,6 项研究的 Jadad 评分为 4 分,4 项研究的 Jadad 评分为 3 分。与对照组相比,酮咯酸能明显减轻0-6小时的疼痛,平均差(MD)为-1.42(95% CI:-2.03 至 -0.80;P 2 = 13%),表明各研究结果一致。PMR 明显下降(SMD = - 1.83;95% CI = - 3.42 至 - 0.23;P 2 = 93%,异质性 P 结论:无论是单独使用还是与其他镇痛药联合使用,酮咯酸都能有效减轻成人腰椎手术后的疼痛并减少阿片类药物的用量。与其他镇痛药或安慰剂相比,酮咯酸不会明显增加术后恶心和呕吐的发生率。虽然酮咯酸还能缩短手术时间,但其临床意义不大。然而,研究设计、剂量和联合疗法的差异性导致了结果的显著异质性。未来的研究应侧重于规范方案和探索最佳剂量策略。此外,还需要进行长期的安全性和有效性研究,以更好地了解酮咯酸在术后疼痛治疗中的作用。
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来源期刊
Systematic Reviews
Systematic Reviews Medicine-Medicine (miscellaneous)
CiteScore
8.30
自引率
0.00%
发文量
241
审稿时长
11 weeks
期刊介绍: Systematic Reviews encompasses all aspects of the design, conduct and reporting of systematic reviews. The journal publishes high quality systematic review products including systematic review protocols, systematic reviews related to a very broad definition of health, rapid reviews, updates of already completed systematic reviews, and methods research related to the science of systematic reviews, such as decision modelling. At this time Systematic Reviews does not accept reviews of in vitro studies. The journal also aims to ensure that the results of all well-conducted systematic reviews are published, regardless of their outcome.
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