Evaluation of Analgesic Treatments for Ankle Sprains in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.
研究概览
简要总结
The aim of this study is to evaluate the short-term effects of routinely applied agents on pain and joint range of motion (ROM) in ankle sprains presenting to the emergency department (ED).
详细描述
It is aimed to examine the effects of intravenous (IV) 50 mg dexketoprofen, IV ibuprofen 400mg and IV paracetamol 10 mg on pain and joint range of motion. To determine the effects of these agents on pain, the easily applicable Numerical Rating Scale (NRS) and Wong-Baker Faces Pain Rating Scale will be used. A standard handheld half-circle goniometer will be utilized to calculate active ankle joint ROM.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older who present to the emergency department within the first 72 hours after ankle sprain.
- •Grade 1 (mild) and Grade 2 (moderate) ankle sprains.
- •Exclusion of fractures and dislocations (after X-ray according to Ottawa rules).
- •Absence of muscle-tendon ruptures.
- •Absence of vascular and nerve injuries.
- •Absence of open wounds and burns.
- •Stable vital signs.
- •Patients who provide written and verbal consent.
排除标准
- •Patients who did not present to the emergency department within the first 72 hours after ankle sprain.
- •Grade 3 (severe) ankle sprains.
- •Multiple traumas.
- •Pregnancy or suspected pregnancy.
- •Ankle fractures and dislocations.
- •Forensic cases.
- •History of previous ankle surgery or fracture.
研究组 & 干预措施
Group Dexketoprofen
Dexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
干预措施: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection (Drug)
Group Dexketoprofen
Dexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
干预措施: isotonic saline (Drug)
Group Ibuprofen
Ibuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
干预措施: Ibuprofen 100 MG/ML Solution for Injection (Drug)
Group Ibuprofen
Ibuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
干预措施: isotonic saline (Drug)
Group Paracetamol
Paracetamol 10 mg/ml will be administered parenterally.
干预措施: Paracetamol 10 Mg/mL Solution for Injection (Drug)
结局指标
主要结局
To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.
时间窗: *Wong-Baker Faces Pain Rating Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment
Wong-Baker FACES pain rating scale (WBS) will be used to assess effects on pain. WBS: This scale uses a series of faces ranging from a smiling face representing "No pain" to a crying face representing "Worst pain" to visually express the intensity of pain.
To evaluate the effectiveness of multimodal treatment methods on Range of Motion in ankle sprains.
时间窗: - 0 minute ROM before treatment - 60 minute ROM after treatment
A standard handheld goniometer will be used to calculate Range of Motion (ROM) measurements. The aim is to determine the effects of multimodal treatment methods routinely applied in emergency services on pain and range of motion and to reveal their superiority over each other, if any. (Normal ROM values: 20° for dorsiflexion, 45° for plantar flexion)
次要结局
未报告次要终点
研究者
Emine Sarcan
Doctor
Ankara Etlik City Hospital