Departamento Medicina Interna, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Sección Medicina Paliativa, Departamento de Medicina Interna, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Of 523, 8330077, Santiago, Chile.
Trials. 2022 Jul 6;23(1):548. doi: 10.1186/s13063-022-06442-2.
Cancer pain is one of the most frequent and relevant symptoms in cancer patients and impacts on patient's quality of life. International and local standards recommend as an initial strategy the use of an analgesic scheme composed of strong opioids associated with adjuvants such as acetaminophen, based upon the assumption that combining drugs could have a better analgesic effect, could allow lowering opioid dosing, and could prevent the occurrence of adverse effects of opioids. However, there is uncertainty about the impact of acetaminophen as an adjuvant in patients who use strong opioids for moderate to severe pain management in cancer patients. The aim of this study is to assess the efficacy and safety of intravenous acetaminophen associated with strong opioids in hospitalized adult cancer patients who have moderate to severe cancer-related pain.
We will perform a randomized double-blinded controlled study comparing intravenous acetaminophen 1 g 4 times a day versus placebo for 48 h as an adjuvant to strong opioids. We will assess pain intensity as a primary outcome, using the verbal numerical rating scale (VNRS, I0 to 10 scale with higher scores meaning higher pain intensity), and we will compare the mean difference in pain intensity between baseline and 48 h among the placebo and intervention groups. We estimate that a decrease of 1 point in the VNRS would be clinically significant. Assuming a standard deviation in pain intensity of 1.7 points, an alpha of 0.025, and a power of 0.8, we estimate a sample size of 112 patients, with 56 patients in each arm. Secondary outcomes include the difference in total opioid use between baseline and at 48 h among the groups, and adverse effects such as drowsiness, constipation, nausea, and vomiting would be evaluated.
The randomized, double-blind, placebo-controlled design is the best strategy to assess the efficacy of acetaminophen as an adjuvant in adult cancer patients with moderate to severe pain who are receiving strong opioids. We expect to contribute to national and international guidelines with these results.
Clinicaltrials.gov NCT04779567 . Registered on March 3, 2021. Retrospectively registered.
癌痛是癌症患者最常见和最相关的症状之一，影响患者的生活质量。国际和国内标准建议将包含强阿片类药物的镇痛方案作为初始策略，同时联合使用辅助药物，如对乙酰氨基酚，其依据是联合使用药物可能会有更好的镇痛效果，可以降低阿片类药物的剂量，并预防阿片类药物不良反应的发生。然而，对于使用强阿片类药物治疗中重度癌痛的患者，辅助使用对乙酰氨基酚的效果仍存在不确定性。本研究旨在评估静脉内给予对乙酰氨基酚联合强阿片类药物治疗中重度癌症相关疼痛的住院成年癌症患者的疗效和安全性。
我们将进行一项随机、双盲、对照研究，比较 48 小时内静脉内给予对乙酰氨基酚 1 g 4 次/天与安慰剂作为强阿片类药物的辅助治疗。我们将使用数字评分量表（VNRS，0-10 分，分值越高表示疼痛强度越高）评估疼痛强度作为主要结局，并比较安慰剂组和干预组在基线和 48 小时时的疼痛强度的平均差异。我们预计 VNRS 评分降低 1 分将具有临床意义。假设疼痛强度的标准差为 1.7 分，α 值为 0.025，功效为 0.8，我们估计每组需要 112 例患者，共 224 例患者。次要结局包括两组在基线和 48 小时时的总阿片类药物使用量的差异，以及嗜睡、便秘、恶心和呕吐等不良反应。
随机、双盲、安慰剂对照设计是评估对乙酰氨基酚作为辅助药物在接受强阿片类药物治疗中重度疼痛的成年癌症患者中的疗效的最佳策略。我们希望这些结果能为国家和国际指南提供参考。
Clinicaltrials.gov NCT04779567。于 2021 年 3 月 3 日注册。回顾性注册。
