Comparison of Ketoprofen Gel to Placebo in Patients Presented With Mechanical Low Back Pain to the Emergency Department: A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- visual analogue scale at 30 minutes
研究概览
简要总结
Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Although parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse effects.
详细描述
Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs (NSAID) and paracetamol are used commonly in these patients. However, these drugs are not out of adverse effects and can not be used in some patients with diverse comorbidities. Gel forms of NSAIDs are used commonly in the outpatient clinics and shown to be effective in these patients by a Cochrane meta-analysis. However, there is no data on the effect of gel forms of analgesics in ED. The application of analgesics in gel forms might be a reasonable alternative to the paranteral drugs with fewer adverse effects.
The present study aimed to reveal the effect of ketoprofen gel in patients presented with low back pain to emergency department.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical low back pain
排除标准
- •Under 18 years old
- •Over 65 years old
- •Pain less than 40 mm in visual analogue scale
- •Allergy to the study drug
- •Drug or alcohol addiction
- •Pregnancy and lactation
研究组 & 干预措施
Ketoprofen
Interventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.
干预措施: Fastjel (Drug)
Placebo
Placebo arm: placebo gel form of ketoprofen
干预措施: Fastjel (Drug)
结局指标
主要结局
visual analogue scale at 30 minutes
时间窗: 30 minutes
次要结局
- Adverse effects(30 minutes)