Treatment Of Fever And Associated Symptoms In The Emergency Department: Which Drug To Choose?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- body temperature
研究概览
简要总结
Fever is a frequent cause of admission to the Emergency Department (ED) around the world. While it can be caused by a wide range of conditions, the most effective treatment based on its etiology is still undetermined. This observational, prospective, single-center study enrolled adult patients who accessed the ED for fever, with the aim to define the most effective treatment for them.
详细描述
Physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I).The primary endpoint was both 1-degree and 1-point reduction in body temperature for all associated symptoms on the Numeric Rating Scale (NRS) after 1 hour (T1). Secondary endpoint was the reduction of at least 2 points on the NRS after two hours (T2). Adverse events, the needing of a rescue therapy and the response based on the underlying etiology (bacterial, viral, or immune/neoplastic) were also evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fever with/without associated symptoms
- •adults who had given their consent to participate in the study.
排除标准
- •age < 18 years old
- •contraindications or allergies to Paracetamol, Ibuprofen or to the combination Paracetamol/Ibuprofen
- •patients unable to take oral drugs
- •patients who did not express their consent to participate to the study
结局指标
主要结局
body temperature
时间窗: 1 hour
the reduction of 1-degree of body temperature after 1 hour (T1) after the drug administration
Numerical Rating Scale (NRS)
时间窗: 1 hour
the reduction of 1-point for all associated symptoms on NRS after 1 hour (T1) after the drug administration. NRS is a "0-10" scale tool to assess pain severity, with zero that means "no pain" and 10 "the worst pain".
次要结局
- adverse events(2 hours)
- rescue therapy(2 hours)
- the reduction of at least 2 points on the Numerical Rating Scale (NRS) after two hours (T2) after the drug administration(2 hours)