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首页> 外文期刊>Clinical therapeutics >Onset of analgesia and analgesic efficacy of tramadol/acetaminophen and codeine/acetaminophen/ibuprofen in acute postoperative pain: a single-center, single-dose, randomized, active-controlled, parallel-group study in a dental surgery pain model.
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Onset of analgesia and analgesic efficacy of tramadol/acetaminophen and codeine/acetaminophen/ibuprofen in acute postoperative pain: a single-center, single-dose, randomized, active-controlled, parallel-group study in a dental surgery pain model.

机译：曲马多/对乙酰氨基酚和可待因/对乙酰氨基酚/布洛芬在急性术后疼痛中的镇痛作用和镇痛效果：在牙科手术疼痛模型中的单中心，单剂量，随机，主动控制，平行组研究。

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BACKGROUND: The combination of tramadol and acetaminophen has demonstrated good efficacy in various clinical pain models. However, there is a need for comparisons of the onset of analgesia and other measures of analgesic efficacy with this combination and other strong combination analgesics for the management of acute pain. OBJECTIVE: The goal of this study was to compare the time to onset of analgesia and other measures of analgesic efficacy with tramadol/acetaminophen 75/650 mg (Tr/Ac) and codeine/acetaminophen/ibuprofen 20/500/400 mg (Co/Ac/Ib) in the management of acute pain after oral surgery. METHODS: This was a single-center, single-dose, randomized, active-controlled, parallel-group study in healthy subjects who had undergone surgical extraction of > or =1 impacted third molar requiring bone removal. When patients reported at least moderate pain after dental surgery (score > or =5 on a 10-point scale), they were randomized to 1 of 2 treatment groups. The time to onset of analgesia was measured using a 2-stopwatch technique. The time to the onset of perceptible and meaningful pain relief, pain intensity, pain relief, patient's overall assessment, and adverse events were recorded for 6 hours after dosing. RESULTS: One hundred twenty-eight subjects participated in the study, 64 in each treatment group. The 2 groups were similar in terms of baseline pain severity and demographic characteristics (mean age, 23.7 and 23.4 years in the Tr/Ac and Co/Ac/Ib groups, respectively; mean body weight, 58.5 and 60.3 kg). The median times to the onset of perceptible pain relief were a respective 21.0 and 24.4 minutes, and the median times to the onset of meaningful pain relief were 56.4 and 57.3 minutes. Mean total pain relief and the sum of pain intensity difference were also similar in the early period after dosing (0-4 hours). However, between 4 and 6 hours, Co/Ac/Ib was associated with significant differences in both variables compared with Tr/Ac (P < 0.05). Although similar through the 4-hour assessment, mean pain intensity difference was significantly greater with Co/Ac/Ib at 5 to 6 hours. The proportion of patients assessing their assigned treatment as good or better was significantly greater with Co/Ac/Ib compared with Tr/Ac (P < 0.05). The safety profile of Tr/Ac was comparable to that of Co/Ac/Ib. CONCLUSIONS: In this small and selected group of subjects, the onset of analgesia and analgesic efficacy of Tr/Ac was comparable to that of Co/Ac/Ib. Tr/Ac provided rapid and effective analgesia for acute postoperative dental pain in this population.
机译：背景：曲马多和对乙酰氨基酚的组合已在各种临床疼痛模型中显示出良好的疗效。但是，需要比较这种镇痛药的发作和其他镇痛效果的量度与该组合和其他强效组合镇痛药的急性疼痛管理。目的：本研究的目的是比较曲马多/对乙酰氨基酚75/650 mg（Tr / Ac）和可待因/对乙酰氨基酚/布洛芬20/500/400 mg（Co / Ac / Ib）处理口腔手术后的急性疼痛。方法：这是一项对健康受试者的单中心，单剂量，随机，主动控制，平行组研究，研究对象接受了手术摘除>或= 1的需要去除骨的第三磨牙。当患者在牙科手术后报告至少中度疼痛时（在10分制中得分>或= 5），他们被随机分配到2个治疗组中的1个。使用2-秒表技术测量镇痛开始的时间。给药后6小时记录可感知的和有意义的疼痛缓解的开始时间，疼痛强度，疼痛缓解，患者的总体评估以及不良事件。结果：128名受试者参加了研究，每个治疗组中有64名受试者。两组的基线疼痛严重程度和人口统计学特征相似（Tr / Ac和Co / Ac / Ib组的平均年龄分别为23.7和23.4岁;平均体重分别为58.5和60.3 kg）。感觉到的疼痛缓解发作的中位时间分别为21.0和24.4分钟，有意义的疼痛缓解发作的中位时间分别为56.4和57.3分钟。在给药后的早期（0-4小时），平均总的疼痛缓解和疼痛强度差异的总和也相似。然而，在4至6小时之间，Co / Ac / Ib与Tr / Ac相比在两个变量上均具有显着差异（P <0.05）。尽管在4小时的评估中相似，但Co / Ac / Ib在5至6小时的平均疼痛强度差异明显更大。与Tr / Ac相比，Co / Ac / Ib评估其指定治疗为好或更好的患者比例显着更高（P <0.05）。 Tr / Ac的安全性与Co / Ac / Ib的安全性相当。结论：在这个小型且选定的对象组中，Tr / Ac的镇痛作用和镇痛效果与Co / Ac / Ib镇痛相当。 Tr / Ac为该人群的急性术后牙科疼痛提供了快速有效的镇痛作用。

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