NCT01539538已完成3 期
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 16
- 主要终点
- Patient Global Satisfaction
研究概览
简要总结
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients who are 18 years or older
- •Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
- •Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery.
排除标准
- •Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- •Patients with an allergy or hypersensitivity to opioids
- •Female patients who are pregnant or breast-feeding
研究组 & 干预措施
Sufentanil NanoTab PCA System/15 mcg
Experimental
干预措施: Sufentanil NanoTab PCA System/15 mcg (Drug)
morphine IV PCA
Active Comparator
干预措施: morphine IV PCA (Drug)
结局指标
主要结局
Patient Global Satisfaction
时间窗: 48 hours
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
次要结局
未报告次要终点
研究者
研究点 (16)
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