Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement Versus Intravenous PCA for Breakthrough Cancer Pain: A Prospective, Randomized, Open Label, Non Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in 11-point scale NRS pain score
研究概览
简要总结
Proportional dose of sublingual fentanyl tablet (Narco®) based on daily opioid requirement versus intravenous PCA for breakthrough cancer pain: A prospective, randomized, open-label, noninferiority trial.
详细描述
Based on the previous around-the-clock analgesic demand compared to IV PCA in cancer pain patients to prepare the basis for the administration of fentanyl sublingual tablets with an initial dose.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-80
- •Cancer pain
- •Admission for the control of cancer pain or consultation for the treatment of cancer pain
- •Stable vital sign
- •ECOG status ≤ 3 for more than 1 or 2 months
- •Opioid-tolerant state
- •No history of using sublingual fentanyl
排除标准
- •Noncancer pain
- •Opioid naive
- •baseline NRS pain score> 4
- •Current using sublingual fentanyl
- •Difficult to assess cancer pain
- •no evidence of disease(cancer)
- •Planned surgical resection of cancer
- •Allergy to fentanyl
- •Severe renal and/or liver function
- •Severe respiratory depression or uncontrolled COPD
研究组 & 干预措施
IV PCA (proportional dosage)
Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15%
干预措施: Intravenous Infusion (Drug)
SL-FTN (equivalent dose for PCA bolus)
Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
干预措施: Sublingual Tablet (Drug)
结局指标
主要结局
Change in 11-point scale NRS pain score
时间窗: 30 minutes after administration
Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
次要结局
- number of additional doses(immediately after the intervention)
- sum of pain intensity difference(SPID)(60 minutes after administration)
- Pain interference(immediately after the intervention)
- Insomnia(immediately after the intervention)
- Depression(immediately after the intervention)
- Satisfaction scale(immediately after the intervention)
- Change in 11-point scale NRS pain score(15, 45, 60 minutes after administration)
研究者
Jeeyoun Moon
Associate Professor
Seoul National University