Fentanyl OR Esketamine for Traumatic PAIN (FORE-PAIN) Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- Change in pain score as measured with Numeric Rating Scale (NRS)
研究概览
简要总结
Fentanyl and esketamine are both standard of care for treatment of acute severe traumatic pain in the prehospital setting in the Netherlands. However, it is not known whether they are equally effective and safe. It is also not known whether intranasal (IN) administration of fentanyl or esketamine is equally effective and safe as intravenous (IV) administration.
The FORE-PAIN trial is a double-blind multi-arm randomized non-inferiority trial comparing Fentanyl IN, esketamine IV and esketamine IN (intervention arms) to fentanyl IV (comparator arm) for prehospital management of traumatic pain. The investigators hypothesize that all intervention arms provide analgesia that is non-inferior to the comparator arm, and that all study arms are equally safe.
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
- Double (Participant, Care Provider)
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
- •age ≥ 18 years
- •pain has been caused by a trauma (any trauma mechanism) that occurred on the same day
- •Emergency Medical Services personnel determines that administration of a strong opioid or esketamine for analgesia is required
- •patient will be transported to a hospital
排除标准
- •(estimated) weight <40 or >100 kg
- •subject does not understand Dutch or English
- •inability to report pain score
- •inability to give IN or IV medication
- •known severe cardiovascular disease
- •pre-eclampsia
- •Glasgow Coma Scale score < 11
- •subject is known to have previously declined participation in medical research
研究组 & 干预措施
Esketamine IN
Anesthetic, in lower doses the analgesic effect is dominant Form: esketamine solution for injection/infusion Administration: intranasal using a nasal atomizer Initial dose: 0.625mg/kg to a maximum of 50mg Second dose (if required): 0.5mg/kg to a maximum total dose of 1mg/kg
干预措施: Esketamine (Drug)
Esketamine IV
Anesthetic, in lower doses the analgesic effect is dominant Form: esketamine solution for injection/infusion Administration: intravenous Initial dose: 0.2mg/kg Second dose (if required): 0.12mg/kg
干预措施: Esketamine (Drug)
Fentanyl IV
Opioid analgesic Form: fentanyl solution for injection/infusion Administration: intravenous Initial dose: 1 ug/kg Second dose (if required): 0.6ug/kg
干预措施: Fentanyl Citrate (Drug)
Fentanyl IN
Opioid analgesic Form: fentanyl solution for injection/infusion Administration: intranasal using nasal atomizer Initial dose: 1.25 ug/kg to a maximum of 100ug Second dose (if required): 1ug/kg to a maximum total dose of 2ug/kg
干预措施: Fentanyl Citrate (Drug)
结局指标
主要结局
Change in pain score as measured with Numeric Rating Scale (NRS)
时间窗: 10 minutes after first drug administration
NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'
次要结局
- Number of subjects requiring a second dose of study medication(10 and 20 minutes after first drug administration)
- Number of patients requiring unblinding(Up to time of arrival at the hospital (expected within 30 minutes after first drug administration))
- Change in pain score as measured with NRS(20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration))
- Number of patients experiencing adverse events(Up to time of arrival at the hospital (expected within 30 minutes after first drug administration))
- Relative change in pain score as measured with NRS(10 and 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration))
- Patient satisfaction with pre-hospital analgesia(Time of arrival at the hospital (expected within 30 minutes after first drug administration))
研究者
Robert Weenink
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)