Dexketoprofen ® IV Versus Piroxicam® IM in Emergency Pain Management
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to pain resolution
研究概览
简要总结
For pain of traumatic origin, the RICE protocol (Rest, Ice, Compression, Elevation) is the main therapeutic measure during the first 4 to 5 days post-trauma. However, there is currently insufficient evidence that this protocol is effective [4].
In the emergency department, paracetamol, NSAIDs or a combination of several molecules are generally prescribed. Patients even use these drugs without a prescription.
The aim of this study is to Compare the effect of dexketoprofen® IV versus piroxen® IM in the treatment of pain in emergency departments.
详细描述
This was a prospective, randomized, double-blind, controlled study conducted at the Sahloul emergency department, Sousse.
Study duration: 3 months.
Inclusion criteria:
Patients over 18 years of age requiring analgesia for acute pain of traumatic origin and who signed a written consent form were included in this study.
Exclusion criteria:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age who required analgesia for acute pain of traumatic origin and who signed a written consent form were included in the study.
排除标准
- •Patients who meet the following conditions:
- •refusal, incapacity, difficulties with consent or communication
- •Patients with chronic pain.
- •Any known allergy or secondary reaction to piroxen or dexketoprofen trometamol.
- •Pregnant women.
- •Cirrhosis of the liver.
研究组 & 干预措施
Dexketoprofen
Patients receive a perfusion of Dexketoprofen in intraveinous with an injection of istonic saline IM injection
干预措施: Dexketoprofen (Drug)
Piroxicam
Patients receive an intramuscular injection of piroxicam with an intravenous isotonic saline
干预措施: Piroxicam (Drug)
结局指标
主要结局
Time to pain resolution
时间窗: 120 minutes
VAS\<3
次要结局
- rescue tratment(120 minutes)
- Side effects(7 days)
- patient satisfaction(7 days)
研究者
Riadh Boukef
professor
Hôpital Universitaire Sahloul