Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Who Are Undergoing Ambulatory Surgery- a Case Series
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Morphine Equivalence
研究概览
简要总结
In this case series study, the investigators are testing the hypothesis that sublingual sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care Unit (PACU) in ambulatory surgery patients taking Suboxone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-100 years
- •Currently taking Suboxone
- •ASA (American Society of Anesthesiology) physical score 1-3
- •Able to provide a signed informed consent
- •General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia
排除标准
- •Known allergic reactions to Dsuvia and its excipients
- •Severe respiratory illness including exacerbation of asthma attack
- •Significant intraoperative hemodynamic instability
- •Use of Regional anesthesia techniques
研究组 & 干预措施
Treatment
Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV.
干预措施: Dsuvia (Drug)
结局指标
主要结局
Morphine Equivalence
时间窗: During day of surgery
Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU).
次要结局
- Adverse Events Post Discharge From PACU(24 hours)
- Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit)(During stay in PACU, up until discharge from PACU)
- Need for Additional Opioids Following Surgery(PACU stay to 24 hours post hospital discharge)
- Time to Take the First Additional Opioid(24 hours post hospital discharge)
- Adverse Events in the PACU(During PACU stay, up until discharge from PACU)