阿片类镇痛药减少研究 (OARS)
2026年8月27日 更新者：Cecile A. Feldman, DMD、Rutgers, The State University of New Jersey
阿片类镇痛药减少研究 (OARS)：管理急性术后手术疼痛
目标是为包括牙医在内的医疗保健专业人员在决定用于急性术后疼痛管理的镇痛药时提供临床决策的最佳证据，将进行一项双盲、分层随机临床试验以检验以下假设非处方非阿片类镇痛药的组合至少与最常用的阿片类镇痛药一样有效（非劣效）。 由于术后疼痛的可预测严重性和结果的普遍性，将使用受影响的第三磨牙拔除模型。
这项双盲、前瞻性、分层、随机的实用临床试验将使用阻生第三磨牙拔除疼痛模型。
研究概览
研究类型
介入性
注册 (实际的)
1815
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Chicago、Illinois、美国、60612
- University of Illinois at Chicago
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan
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New Jersey
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Newark、New Jersey、美国、07101
- Rutgers School of Dental Medicine
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New York
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Rochester、New York、美国、14620
- University of Rochester
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
描述
纳入标准：
个人必须满足以下所有条件才有资格参与研究：
- 能够理解知情同意。
- 提供签署并注明日期的知情同意书
- 能够用英语理解数据收集仪器的所有说明
- 愿意并能够遵守所有研究程序，并在研究期间随时待命
- 计划拔除一颗或多颗部分或完全阻生的下颌第三磨牙
- 年满 18 岁
- 病史证明身体健康
参与本研究的女性必须同意使用以下避孕方法之一：
- 避孕药
- 宫内节育器
- 避孕套
- 节制
排除标准：
自我报告以下历史的参与者将被排除在参与之外：
- 消化道出血和/或消化性溃疡病史
- 肾病史（不包括肾结石）
- 肝病史
- 出血性疾病史
- 呼吸抑制史
- 阿片类药物或其他需要术后呼吸支持的麻醉药物的先前呼吸作用
- 活动性或未经治疗的哮喘
- 已知对布洛芬、对乙酰氨基酚、氢可酮和/或麻醉的寓言反应史
目前正在服用以下任何药物：
- CYP3A4 抑制剂，如大环内酯类抗生素（如红霉素）、唑类抗真菌药（如酮康唑）和蛋白酶抑制剂（如利托那韦），可能会增加酒石酸氢可酮和对乙酰氨基酚的血浆浓度并延长阿片类药物的不良反应，并且可能导致潜在致命的呼吸抑制
- 中枢神经系统抑制剂。
- 每天喝 3 杯或更多酒精饮料和/或有酗酒史
- 吸毒或酗酒史
- 一级亲属吸毒或酗酒的家族史
- 在过去 12 个月内开出的阿片类药物处方不超过一份
- 目前怀孕或哺乳
参与者也将因任何其他标准而被排除在外，这些标准会使个人面临更高的风险或妨碍个人完全遵守或完成研究，其中包括：
- 先前参与本研究
- 无法或拒绝提供知情同意
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：阿片类药物
氢可酮 5 毫克/对乙酰氨基酚 300 毫克和安慰剂药片的联合镇痛剂。
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氢可酮/对乙酰氨基酚组合产品
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有源比较器：非阿片类药物
布洛芬 400 毫克/对乙酰氨基酚 500 毫克的组合
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非处方镇痛药（布洛芬/对乙酰氨基酚）的组合
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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最痛 1
大体时间：手术当天结束时（第一天）和第二天早上醒来时（手术后一晚）
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参与者被要求以 0 到 10 的 NRS 等级对他们在白天（睡觉前记录）和夜间（醒来时记录）经历的最严重疼痛进行评分，其中 0=无疼痛，10=尽可能严重的疼痛想象。
最严重疼痛 1 是手术当天结束时（第 1 天）和第二天早上醒来时（手术后 1 晚）提供的评分的平均值。
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手术当天结束时（第一天）和第二天早上醒来时（手术后一晚）
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最痛2
大体时间：手术后一天结束时（第二天）和第二天早上醒来时（手术后第二天晚上）
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参与者被要求以 0 到 10 的 NRS 等级对他们在白天（睡觉前记录）和夜间（醒来时记录）经历的最严重疼痛进行评分，其中 0=无疼痛，10=尽可能严重的疼痛想象。
最严重疼痛 2 是手术后当天结束时（第 2 天）和第二天早上醒来时（手术后第 2 天晚上）提供的评分的平均值。
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手术后一天结束时（第二天）和第二天早上醒来时（手术后第二天晚上）
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最痛 3
大体时间：手术后第2天结束时（第3天）和第二天早上醒来时（手术后第3晚）
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参与者被要求以 0 到 10 的 NRS 等级对他们在白天（睡觉前记录）和夜间（醒来时记录）经历的最严重疼痛进行评分，其中 0=无疼痛，10=尽可能严重的疼痛想象。
最严重疼痛 3 是手术后第 2 天结束时（第 3 天）和第二天早上醒来时（手术后第 3 天晚上）提供的评分的平均值。
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手术后第2天结束时（第3天）和第二天早上醒来时（手术后第3晚）
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疼痛最严重
大体时间：手术后前 7 天结束时（第 1 天至第 7 天）以及前 7 个早晨醒来时（手术后第 1 天至第 7 天晚上）
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参与者被要求以 0 到 10 的 NRS 等级对他们在白天（睡觉前记录）和夜间（醒来时记录）经历的最严重疼痛进行评分，其中 0=无疼痛，10=尽可能严重的疼痛想象。
最糟糕的疼痛是手术后前 7 天（第 1 天至第 7 天）结束时以及前 7 个早晨醒来时（手术后第 1 天至第 7 天晚上）提供的评分的平均值。
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手术后前 7 天结束时（第 1 天至第 7 天）以及前 7 个早晨醒来时（手术后第 1 天至第 7 天晚上）
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疼痛平均 1
大体时间：手术当天结束时（第一天）和第二天早上醒来时（手术后一晚）
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参与者被要求以 0 到 10 的 NRS 等级对他们白天（睡觉前记录）和夜间（醒来时记录）经历的平均疼痛进行评分，其中 0=无疼痛，10=尽可能严重的疼痛想象。
平均疼痛 1 是手术当天结束时（第 1 天）和第二天早上醒来时（手术后 1 晚）提供的评分的平均值
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手术当天结束时（第一天）和第二天早上醒来时（手术后一晚）
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平均疼痛 2
大体时间：手术后当天结束时（第二天）和第二天早上醒来时（手术后第二天晚上）
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参与者被要求以 0 到 10 的 NRS 等级对他们白天（睡觉前记录）和夜间（醒来时记录）经历的平均疼痛进行评分，其中 0=无疼痛，10=尽可能严重的疼痛想象。
平均疼痛 2 是手术后当天结束时（第 2 天）和第二天早上醒来时（手术后第 2 天晚上）提供的评分的平均值。
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手术后当天结束时（第二天）和第二天早上醒来时（手术后第二天晚上）
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疼痛平均 3
大体时间：手术后第2天结束时（第3天）和第二天早上醒来时（手术后第3晚）
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参与者被要求以 0 到 10 的 NRS 等级对他们白天（睡觉前记录）和夜间（醒来时记录）经历的平均疼痛进行评分，其中 0=无疼痛，10=尽可能严重的疼痛想象。
平均疼痛 3 是手术后第 2 天结束时（第 3 天）和第二天早上醒来时（手术后第 3 天晚上）提供的评分的平均值。
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手术后第2天结束时（第3天）和第二天早上醒来时（手术后第3晚）
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疼痛平均所有
大体时间：手术后前 7 天结束时（第 1 天至第 7 天）以及前 7 个早晨醒来时（手术后第 1 天至第 7 天晚上）
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参与者被要求以 0 到 10 的 NRS 等级对他们白天（睡觉前记录）和夜间（醒来时记录）经历的平均疼痛进行评分，其中 0=无疼痛，10=尽可能严重的疼痛想象。
平均疼痛是手术后前 7 天（第 1 天到第 7 天）结束时以及前 7 个早上醒来时（手术后第 1 到第 7 个晚上）提供的评分的平均值。
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手术后前 7 天结束时（第 1 天至第 7 天）以及前 7 个早晨醒来时（手术后第 1 天至第 7 天晚上）
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总体满意度
大体时间：术后访视时（第 9 天 +/- 5 天）
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参与者对以下问题的五点李克特量表评分（1=非常满意，2=满意，3=既不满意也不满意，4=不满意，5=非常不满意）：“总体而言，您对当前止痛药的满意度如何？”
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术后访视时（第 9 天 +/- 5 天）
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复合疼痛1
大体时间：手术当天结束时（第一天）和第二天早上醒来时（手术后一晚）
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入睡前，参与者被要求评价他们白天“经历过的最严重的疼痛”、“经历过的最轻的疼痛”和“经历过的平均疼痛”以及“现在的疼痛”。
醒来后，参与者被要求评价他们夜间“经历的最严重的疼痛”、“经历的最少的疼痛”和“经历的平均疼痛”以及“现在的疼痛”。
使用 0 到 10 的 NRS 等级，其中 0=无疼痛，10=疼痛程度如您所想象。
复合疼痛 1 是手术当天结束时（第 1 天）和第二天早上醒来时（手术后 1 晚）提供的所有评分的平均值。
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手术当天结束时（第一天）和第二天早上醒来时（手术后一晚）
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复合疼痛2
大体时间：手术后第二天（第二天）的一天结束时和第二天早上醒来时（手术后的第二天晚上）
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入睡前，参与者被要求评价他们白天“经历过的最严重的疼痛”、“经历过的最轻的疼痛”和“经历过的平均疼痛”以及“现在的疼痛”。
醒来后，参与者被要求评价他们夜间“经历的最严重的疼痛”、“经历的最少的疼痛”和“经历的平均疼痛”以及“现在的疼痛”。
使用 0 到 10 的 NRS 等级，其中 0=无疼痛，10=疼痛程度如您所想象。
复合疼痛 2 是手术后第二天（第 2 天）和第二天早上醒来时（手术后第 2 天晚上）提供的所有评分的平均值。
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手术后第二天（第二天）的一天结束时和第二天早上醒来时（手术后的第二天晚上）
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复合疼痛3
大体时间：手术后第三天（第三天）的一天结束时和第二天早上醒来时（手术后第三晚）
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入睡前，参与者被要求评价他们白天“经历过的最严重的疼痛”、“经历过的最轻的疼痛”和“经历过的平均疼痛”以及“现在的疼痛”。
醒来后，参与者被要求评价他们夜间“经历的最严重的疼痛”、“经历的最少的疼痛”和“经历的平均疼痛”以及“现在的疼痛”。
使用 0 到 10 的 NRS 等级，其中 0=无疼痛，10=疼痛程度如您所想象。
复合疼痛 3 是手术后两天（第 3 天）和手术后第 3 个早晨醒来时（手术后第 3 个晚上）提供的所有评分的平均值。
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手术后第三天（第三天）的一天结束时和第二天早上醒来时（手术后第三晚）
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复合疼痛全部
大体时间：手术后前 7 天结束时（第 1 天至第 7 天）以及前 7 个早晨醒来时（手术后第 1 天至第 7 天晚上）
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入睡前，参与者被要求评价他们白天“经历过的最严重的疼痛”、“经历过的最轻的疼痛”和“经历过的平均疼痛”以及“现在的疼痛”。
醒来后，参与者被要求评价他们夜间“经历的最严重的疼痛”、“经历的最少的疼痛”和“经历的平均疼痛”以及“现在的疼痛”。
使用 0 到 10 的 NRS 等级，其中 0=无疼痛，10=疼痛程度如您所想象。
综合疼痛全部是手术后前 7 天（第 1 天至第 7 天）结束时以及前 7 个早晨醒来时（手术后第 1 天至第 7 天晚上）提供的评分的平均值。
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手术后前 7 天结束时（第 1 天至第 7 天）以及前 7 个早晨醒来时（手术后第 1 天至第 7 天晚上）
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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接受救援药物的参与者人数
大体时间：术后访视时（术后 9 天 +/- 5 天）
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接受额外止痛药（羟考酮）作为研究镇痛药的参与者不能充分控制疼痛
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术后访视时（术后 9 天 +/- 5 天）
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疼痛干扰1
大体时间：手术当天结束（第一天）
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参与者被要求以 5 点李克特量表来评分，疼痛对他们的日常活动、家庭工作、参与社交活动的能力、生活享受、你通常做的有趣的事情、享受的干扰程度社交活动、家务、家庭生活、集中注意力的能力、娱乐活动的享受、外出任务{规模：1=完全没有、2=一点、3=有一点、4=相当多、5 =非常}以及疼痛有多少次让您无法与他人交往？
{scale=1=从不、2=很少、3=有时、4=经常、5=总是} 疼痛干扰 1 是手术当天结束时提供的平均评分。
分数越低越好。
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手术当天结束（第一天）
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疼痛干扰2
大体时间：手术后第一天结束（第 2 天）
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参与者被要求以 5 点李克特量表来评分，疼痛对他们的日常活动、家庭工作、参与社交活动的能力、生活享受、你通常做的有趣的事情、享受的干扰程度社交活动、家务、家庭生活、集中注意力的能力、娱乐活动的享受、外出任务{规模：1=完全没有、2=一点、3=有一点、4=相当多、5 =非常}以及疼痛有多少次让您无法与他人交往？
{scale=1=从不、2=很少、3=有时、4=经常、5=总是} 疼痛干扰 2 是手术后一天结束时（第 2 天）提供的平均评分。
分数越低越好。
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手术后第一天结束（第 2 天）
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疼痛干扰3
大体时间：手术后第二天结束（第 3 天）
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参与者被要求以 5 点李克特量表来评分，疼痛对他们的日常活动、家庭工作、参与社交活动的能力、生活享受、你通常做的有趣的事情、享受的干扰程度社交活动、家务、家庭生活、集中注意力的能力、娱乐活动的享受、外出任务{规模：1=完全没有、2=一点、3=有一点、4=相当多、5 =非常}以及疼痛有多少次让您无法与他人交往？
{scale=1=从不、2=很少、3=有时、4=经常、5=总是} 疼痛干扰 3 是手术后第二天（第 3 天）结束时提供的平均评分。
分数越低越好。
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手术后第二天结束（第 3 天）
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疼痛干扰全部
大体时间：手术后前 7 天
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参与者被要求以 5 点李克特量表来评分，疼痛对他们的日常活动、家庭工作、参与社交活动的能力、生活享受、你通常做的有趣的事情、享受的干扰程度社交活动、家务、家庭生活、集中注意力的能力、娱乐活动的享受、外出任务{规模：1=完全没有、2=一点、3=有一点、4=相当多、5 =非常}以及疼痛有多少次让您无法与他人交往？
{scale=1=从不、2=很少、3=有时、4=经常、5=总是} 疼痛干扰 ALL 是手术后第 1 个 7 天（第 1 天至第 7 天）结束时提供的平均评分。
分数越低越好。
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手术后前 7 天
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睡眠 1
大体时间：手术后第二天第一次醒来时
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参与者被要求对手术后第一晚的整体睡眠质量进行评分，NRS 等级为 0 到 10，其中 0 = 优秀，10 = 非常差。
睡眠 1 是手术后第二天第一次醒来时提供的评级。
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手术后第二天第一次醒来时
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睡眠2
大体时间：手术后第二天第一次醒来时
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参与者被要求对手术后第二天晚上的整体睡眠质量进行评分，NRS 等级为 0 到 10，其中 0 = 优秀，10 = 非常差。
睡眠 2 是手术后第二天第一次醒来时提供的评级。
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手术后第二天第一次醒来时
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睡眠 3
大体时间：手术后第三天第一次醒来时
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参与者被要求对手术后第三晚的整体睡眠质量进行评分，NRS 等级为 0 到 10，其中 0 = 优秀，10 = 非常差。
睡眠 1 是手术后第三天第一次醒来时提供的评级。
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手术后第三天第一次醒来时
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全部睡觉
大体时间：手术后前 7 晚
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参与者被要求按照 0 到 10 的 NRS 等级对手术后前 7 个晚上的整体睡眠质量进行评分，其中 0 = 优秀，10 = 非常差。
Sleep All 是所有七晚的平均评分。
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手术后前 7 晚
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阿片类药物片剂转移的潜力
大体时间：术后访视时（术后 9 天 +/- 5 天）
|
术后回访时返回的阿片类镇痛胶囊数量（术后 9 天 +/- 5 天）
|
术后访视时（术后 9 天 +/- 5 天）
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite Pain 1 by Sex
大体时间：End of day of surgery (day 1) and when waking up the next morning (1 )
|
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now."
Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now."
A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used.
Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
|
End of day of surgery (day 1) and when waking up the next morning (1 )
|
|
Composite Pain 2 by Sex
大体时间：End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
|
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now."
Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now."
A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used.
Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
|
End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
|
|
Composite Pain 3 by Sex
大体时间：End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now."
Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now."
A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used.
Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
|
End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
|
Composite Pain All by Sex
大体时间：End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
NIH Required Analysis - Description Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now."
Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now."
A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used.
Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
|
End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
|
Overall Satisfaction by Sex
大体时间：At time of post-operative visit (day 9 +/- 5 days)
|
NIH Required Analysis - Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
|
At time of post-operative visit (day 9 +/- 5 days)
|
|
Pain Worst 1 by Sex
大体时间：End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
|
End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
|
Pain Worst 2 by Sex
大体时间：End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
|
End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
|
Pain Worst 3 by Sex
大体时间：e End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
|
e End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
|
Pain Worst All by Sex
大体时间：End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
|
End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
|
Pain Average 1 by Sex
大体时间：End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
|
Pain Average 2 by Sex
大体时间：End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
|
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
|
End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
|
|
Pain Average 3 by Sex
大体时间：End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
|
End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
|
Pain Average All by Sex
大体时间：End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
|
End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
|
Composite Pain 1 by Race Ethnicity
大体时间：End of day of surgery (day 1) and when waking up the next morning (1 )
|
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now."
Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now."
A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used.
Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
|
End of day of surgery (day 1) and when waking up the next morning (1 )
|
|
Composite Pain 2 by Race Ethnicity
大体时间：End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
|
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now."
Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now."
A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used.
Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
|
End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
|
|
Composite Pain 3 by Race Ethnicity
大体时间：End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now."
Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now."
A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used.
Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
|
End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
|
Composite Pain All by Race and Ethnicity
大体时间：End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
NIH Required Analysis - Description Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now."
Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now."
A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used.
Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
|
End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
|
Overall Satisfaction by Race Ethnicity
大体时间：At time of post-operative visit (day 9 +/- 5 days)
|
NIH Required Analysis - Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
|
At time of post-operative visit (day 9 +/- 5 days)
|
|
Pain Worst 1 by Race Ethnicity
大体时间：End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
|
End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
|
Pain Worst 2 by Race Ethnicity
大体时间：End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
|
End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
|
Pain Worst 3 by Race Ethnicity
大体时间：e End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
|
e End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
|
Pain Worst All by Race Ethnicity
大体时间：End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
|
End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
|
Pain Average 1 by Race Ethnicity
大体时间：End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
|
|
Pain Average 2 by Race Ethnicity
大体时间：End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
|
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
|
End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
|
|
Pain Average 3 by Race Ethnicity
大体时间：End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
|
End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
|
|
Pain Average All by Race Ethnicity
大体时间：End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine.
Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
|
End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Cecile A Feldman, DMD、Rutgers, The State University of New Jersey
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Feldman CA, Fredericks-Younger J, Lu SE, Desjardins PJ, Malmstrom H, Miloro M, Warburton G, Ward B, Ziccardi V, Fine D. The Opioid Analgesic Reduction Study (OARS)-a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial. Trials. 2022 Feb 17;23(1):160. doi: 10.1186/s13063-022-06064-8.
- Feldman CA, Fredericks-Younger J, Desjardins PJ, Malmstrom H, Miloro M, Warburton G, Ward BB, Ziccardi VB, Greenberg P, Andrews T, Matheson PB, Benoliel R, Fine DH, Lu SE. Nonopioid vs opioid analgesics after impacted third-molar extractions: The Opioid Analgesic Reduction Study randomized clinical trial. J Am Dent Assoc. 2025 Feb;156(2):110-123.e9. doi: 10.1016/j.adaj.2024.10.014. Epub 2025 Jan 4.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月4日
初级完成 (实际的)
2023年7月7日
研究完成 (实际的)
2023年12月24日
研究注册日期
首次提交
2020年4月7日
首先提交符合 QC 标准的
2020年6月29日
首次发布 (实际的)
2020年6月30日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Pro2020002299
- 5UH3DE028860-05 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
电子数据采集 (EDC) 将在整个研究过程中广泛使用，以收集患者数据以及推动运营/后勤工作流程。
带有数据字典的数据库将可用。
IPD 共享时间框架
出版后 12 个月
IPD 共享访问标准
从 PI 请求数据访问。
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.