Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Recovery Room Time
研究概览
简要总结
The purpose of this study is to determine if a single dose of sublingual sufentanil is as or more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.
详细描述
This is a level I randomized prospective outcomes study comparing two groups of patients. Upon arrival in the ambulatory surgery center (ASC) post-anesthesia care unit (PACU) if the patient has a pain score of 4 or greater they will then be randomized to one of two groups. Group 1 will receive 50 mcg of IV fentanyl and group 2 will receive 30 mcg of sublingual sufentanil. The primary outcome assessed will be time of readiness to discharge after arrival in the post-anesthesia care unit.
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
- •undergoing outpatient ambulatory surgery
- •recipient of general anesthesia
- •pain score of 4 or greater in the PACU
排除标准
- •non-english speaking patients
- •cancer surgeries
- •patients who have allergy or intolerance to the study drugs or derivatives
- •patients on chronic opioids (defined as daily opioids for 3 months or longer)
研究组 & 干预措施
Sublingual Sufentanil
Single dose of sublingual sufentanil for acute pain.
干预措施: Sublingual Sufentanil (Drug)
IV Fentanyl
single dose of IV fentanyl for acute pain.
干预措施: IV Fentanyl (Drug)
结局指标
主要结局
Recovery Room Time
时间窗: 1 day
The time (reported in minutes) from when the patient arrives in the PACU, right after surgery, to the time that all discharge criteria are met.
次要结局
- Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)(1 day)
- Adverse Events(1 day)
- Postoperative Nausea and Vomiting (PONV)(1 day)
- Supplemental Oxygen(1 day)
- Overall Benefit of Analgesic Score (OBAS)(1 day)