Pamukkale University Medical School,Dept. of Emergency Medicine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Reduction in visual analogue scale
研究概览
简要总结
This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.
详细描述
Study Design and Setting:
This is a single-center, prospective, randomized, double-blind, clinical trial performed in an ED of a tertiary care hospital with annual census of approximately 37.000 visits. The local ethics committee approved the study.
Interventions:
We conducted a randomized, controlled clinical trial comparing single intravenous doses of paracetamol (1 g), dexketoprofen (50 mg) and morphine (0.1 mg/kg) for patients presenting to the emergency department (ED) with suspected low back pain. Subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg). We compared changes in pain intensity 30 minutes after treatment.
Methods of Measurements:
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
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (aged 16 to 55 years) with acute low back pain were eligible for inclusion in the study- -
排除标准
- •Exclusion criteria included known allergy or contraindication to morphine, paracetamol,dexketoprofen or any opioid analgesic
- •Hemodynamic instability
- •Fever (temperature >38°C [100.4°F])
- •Evidence of peritoneal inflammation
- •Documented or suspected pregnancy
- •Known or suspected aortic dissection or aneurysm, lombar disc hernia
- •Use of any analgesic within 6 hours of ED presentation
- •Previous study enrollment.
- •Patients with known renal, pulmonary, cardiac, or hepatic failure, as well as those with renal transplantation, were also excluded.
研究组 & 干预措施
morphine
干预措施: Paracetamole (Drug)
Paracetamole, dexketoprofen
Paracetamole, dexketoprofen
干预措施: paracetamol (Drug)
Paracetamole, dexketoprofen
Paracetamole, dexketoprofen
干预措施: morphine (Drug)
Paracetamole, dexketoprofen
Paracetamole, dexketoprofen
干预措施: Dexketoprofen (Drug)
结局指标
主要结局
Reduction in visual analogue scale
时间窗: 15 minutes interval
The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered
次要结局
- Adverse events.(30 minutes after)
研究者
Mustafa Serinken
Pamukkale University
Pamukkale University