Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual analogue scale
研究概览
简要总结
The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.
详细描述
Patients, 18-65 years old, presented with ankle sprain are enrolled into the study. Pain over 24 hours, pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse and pregnancy or breastfeeding are the exclusion criteria. The study interventions are 2 gr of 2.5% ketoprofen gel versus placebo applied to the sprain area. The study drugs are identical in colour, form and smelling. After an eligible patient presented to the ED, the drug number from an opaque bag is determined by a nurse and then another nurse applies the study drug to the patient. Physicians, nurses and patients are blinded to the study drug. Pain intensity of patients is measured by visual analogue scale at baseline, 15th and 30th minutes after the administration.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patient presented with ankle sprain to the emergency department.
- •Patients between 18-65 years old.
排除标准
- •Pain over 24 hours,
- •Pain intensity lower than 40 mm,
- •allergy to the study drug,
- •drug alcohol abuse
- •pregnancy or breastfeeding are the exclusion criteria.
研究组 & 干预措施
ketoprofen
Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr.
干预措施: Ketoprofen gel (Drug)
Placebo
Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analogue scale
时间窗: 30 minutes
Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.
次要结局
- Adverse effects(30 minutes)
研究者
Cenker Eken
Associate Professor
Akdeniz University
