Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1).
研究概览
简要总结
The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.
详细描述
The investigators enrolled 170 consecutive patients with femur fracture and severe pain. The patients received an initial analgesic treatment with paracetamol orally (OR) or intravenously (IV). The primary outcome was the reduction of pain of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1). Secondary endpoints included the reduction of pain of at least 2 points on the VAS scale at the 4 th hour (T4), the need of rescue therapy and the number of adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
- •Femur Fracture
- •Patients who signed the informed consent
- •Able to take analgesic therapy both orally (OR) and intravenously (IV)
- •Able to define pain by VAS
排除标准
- •Age <18 years
- •Allergy to paracetamol
- •Unable to take analgesic therapy both orally (OR) and intravenously (IV)
- •Unable to define pain by VAS
研究组 & 干预措施
Paracetamol IV
Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV).
干预措施: Paracetamol (Drug)
Paracetamol OR
Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR).
干预措施: Paracetamol (Drug)
结局指标
主要结局
Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1).
时间窗: Baseline and 1 hour
The Visual Analogue Scale for Pain (VAS) is a validated self-reported instrument that identifies pain from 0 to 10 (with 0 = no pain and 10 = maximum pain intensity)
次要结局
- Pain change of at least 2 points on the VAS scale at the 4 th hour (T4)(Baseline and 4 hours)