Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the ER - a Double-blind Randomized Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Pain - Relief
研究概览
简要总结
The purpose of this study is to determine the non-inferiority of the efficacy of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.
详细描述
Fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. Fentanyl sublingual (Abstral ®) is an excellent analgesic drug in the breakthrough pain relief in oncologic patients.
The immediate (10 minutes) effect and the ease of administration of sublingual fentanyl could be a possibility for a fast pain relief in remote areas such as mountain rescue missions.
Patients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev.
Safety issues like control of vital signs will be warranted
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, Care Provider, Investigator)
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
- •Trauma on the limbs with a pain score of 4 or more
- •ASA I - II
排除标准
- •children < 18 years
- •cognitive impairment: brain injury, intoxication, analgesia
- •weight under 50 kg and more then 100 kg
- •other injuries like chest trauma with respiratory insufficiency, suspect liver or spleen injury, amputation;
- •chronic analgesic use or misuse
- •fear of needles
- •pregnancy
- •speech difficulties
研究组 & 干预措施
Fentanyl sublingual + Placebo ev
Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev
干预措施: Placebo ev (Drug)
Fentanyl sublingual + Placebo ev
Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev
干预措施: Fentanyl sublingual (Drug)
Fentanyl ev + Placebo sublingual
Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual
干预措施: Fentanyl ev (Drug)
Fentanyl ev + Placebo sublingual
Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual
干预措施: Placebo sublingual (Drug)
结局指标
主要结局
Pain - Relief
时间窗: 1 hour
Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)
次要结局
- SpO2 (%)(1 hour)
- Practicability / handling of the two dosage forms of fentanyl in emergencies(1 hour)
- Patient comfort(1 hour)
- Adverse drug effects(1 hour)
研究者
Elisabeth Gruber
MD
Azienda Sanitaria dell'Alto Adige