The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- change in pain score
研究概览
简要总结
Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.
详细描述
In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm.
The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil.
Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.
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
- •posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more
排除标准
- •<18 years
- •prisoners
- •lesions of head, face or abdomen
- •no consent given or possible
- •pain not scorable
- •known drug abuse or substitution therapy
- •chronic level 3 pain medication
- •intake of level 3 < 8 hours
- •intoxicated patient
- •allergy or intolerance to opiates
- •renal or hepatic insufficiency
- •< 50kg body weight
- •hemodynamic instability
研究组 & 干预措施
intervention
intranasal Sufentanil
干预措施: Sufentanil (Drug)
结局指标
主要结局
change in pain score
时间窗: 15-20 minutes after first administration of Sufentanil
pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)
次要结局
- change in pain score(60 minutes after first administration of Sufentanil)