Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- SPID-12
研究概览
简要总结
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for bunion surgery
排除标准
- •daily opioid use
- •drug or alcohol abuse
- •pregnant or breastfeeding women
研究组 & 干预措施
Sufentanil NanoTab 20 mcg
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
干预措施: Sufentanil NanoTab 20 mcg (Drug)
Sufentanil NanoTab 30 mcg
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
干预措施: Sufentanil NanoTab 30 mcg (Drug)
Placebo NanoTab
Placebo NanoTab as needed every 60 minutes for 12 hours
干预措施: Placebo NanoTab (Drug)
结局指标
主要结局
SPID-12
时间窗: 12 hours
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
次要结局
未报告次要终点