NCT04387136已完成4 期
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival
研究概览
简要总结
The purpose of this study is to determine if a single dose of sublingual sufentanil given 15-30 minutes prior to wake up is efficacious at reducing recovery room time.
详细描述
This is a level I randomized prospective outcomes study comparing two groups of patients. Within 15-30 minutes of planned wake-up Group 1 will receive 30 mcg of sublingual sufentanil and group 2 will not receive sublingual sufentanil.
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
- Triple (Participant, 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
- •Adult patients undergoing outpatient ambulatory surgery undergoing general anesthesia for orthopedic surgery
排除标准
- •non-english speaking patients
- •patients who have allergy or intolerance to the study drugs or derivatives
研究组 & 干预措施
Sublingual Sufentanil
Experimental
Participants in this arm will receive the intervention.
干预措施: Sublingual Sufentanil (Drug)
结局指标
主要结局
Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival
时间窗: 2 hours
Pain is assessed on a scale of 0-10 (whole numbers). A score of 0 being no pain, 10 being maximum imaginable pain. Data collected upon arrival to Post-Anesthesia Care Unit (PACU).
次要结局
- OBAS Score(2 hours)
- Opioid Use in Recovery Room(2 hours)
研究者
研究点 (1)
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