Yin Feng, Ma Wei, Liu Qiao, Xiong Liu-Lin, Wang Ting-Hua, Li Qian, Liu Fei
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Department of Anesthesiology, Chenzhou No. 1 People's Hospital, Chenzhou, Hunan, China.
Front Pharmacol. 2022 Jul 22;13:909572. doi: 10.3389/fphar.2022.909572. eCollection 2022.
Acetaminophen is an important component of a multimodal analgesia strategy to reduce opioid consumption and pain intensity after an orthopedic surgery. The opioid-sparing efficacy of intravenous acetaminophen has been established at a daily dose of 4 g. However, it is still unclear for the daily dose of 2 g of acetaminophen, which is recommended by the China Food and Drug Administration Center for Drug Evaluation, in terms of its efficacy and safety. This study aimed to evaluate the efficacy and safety of intravenous acetaminophen at a daily dose of 2 g for reducing opioid consumption and pain intensity after orthopedic surgery. In this multicenter, randomized, double-blind, placebo-controlled phase III trial, 235 patients who underwent orthopedic surgery were randomly assigned to receive intravenous acetaminophen 500 mg every 6 h or placebo. Postoperative morphine consumption, pain intensity at rest and during movement, and adverse events were analysed. For the mean (standard deviation) morphine consumption within 24 h after surgery, intravenous acetaminophen was superior to placebo both in the modified intention-to-treat analysis [8.7 (7.7) mg vs. 11.2 (9.2) mg] in the acetaminophen group and the placebo group, respectively. Difference in means: 2.5 mg; 95% confidence interval, 0.25 to 4.61; = 0.030), and in the per-protocol analysis (8.3 (7.0) mg and 11.7 (9.9) mg in the acetaminophen group and the placebo group, respectively. Difference in means: 3.4 mg; 95% confidence interval: 1.05 to 5.77; = 0.005). The two groups did not differ significantly in terms of pain intensity and adverse events. Our results suggest that intravenous acetaminophen at a daily dose of 2 g can reduce morphine consumption by Chinese adults within the first 24 h after orthopedic surgery, but the extent of reduction is not clinically relevant. : [ClinicalTrials.gov], identifier [NCT02811991].
对乙酰氨基酚是多模式镇痛策略的重要组成部分，用于减少骨科手术后的阿片类药物用量和疼痛强度。静脉注射对乙酰氨基酚的阿片类药物节省疗效已在每日剂量4克时得到证实。然而，中国国家食品药品监督管理总局药品审评中心推荐的每日2克对乙酰氨基酚剂量，其疗效和安全性仍不明确。本研究旨在评估每日剂量2克的静脉注射对乙酰氨基酚在减少骨科手术后阿片类药物用量和疼痛强度方面的疗效和安全性。在这项多中心、随机、双盲、安慰剂对照的III期试验中，235例接受骨科手术的患者被随机分配接受每6小时静脉注射500毫克对乙酰氨基酚或安慰剂。分析术后吗啡用量、静息和活动时的疼痛强度以及不良事件。对于术后24小时内的平均（标准差）吗啡用量，在改良意向性分析中，静脉注射对乙酰氨基酚在对乙酰氨基酚组和安慰剂组均优于安慰剂[分别为8.7（7.7）毫克和11.2（9.2）毫克]。均值差异：2.5毫克；95%置信区间，0.25至4.61；P = 0.030），在符合方案分析中（对乙酰氨基酚组和安慰剂组分别为8.3（7.0）毫克和11.7（9.9）毫克）。均值差异：3.4毫克；95%置信区间：1.05至5.77；P = 0.005）。两组在疼痛强度和不良事件方面无显著差异。我们的结果表明，每日剂量2克的静脉注射对乙酰氨基酚可在骨科手术后的头24小时内减少中国成年人的吗啡用量，但减少程度在临床上无显著意义。[ClinicalTrials.gov]，标识符[NCT02811991]
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