Comparison of the Analgesic Efficacy of Lidocaine Spray Versus Tramadol and Fentanyl for Pain Control in Rib Fractures: A Prospective, Randomized, Controlled and Open-label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain control
研究概览
简要总结
In this study, we aimed to compare the analgesic efficacy of lidocaine spray with tramadol hydrochloride and fentanyl citrate in rib fractures.
详细描述
Patients over the age of 18 who came to our emergency department with blunt chest trauma were divided into three groups. Groups was created from patients who were given lidocaine 10% spray (local), i.v. 100 mg of tramadol and i.v. fentanyl 50 mcg. A total of 48 patients, each of whom were 16, were included in the study. Numerical rating scale (NRS) pain scores of the patients at baseline, 15th, 30th and 60th minutes were compared. These scores and the amount of falls at follow-up were analyzed comparatively between the 3 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open conscious
- •Oriented and cooperative
- •Blunt thoracic trauma and rib fracture
- •Numerical rating scale (NRS) was 5 or higher
排除标准
- •Patients who refused to participate in the study
- •Detected or suspected pregnancy
- •Known history of allergy or other adverse reaction to the drugs used in the study
- •History of sedative drug use or drug addiction
- •Analgesic use within 6 hours of admission to the emergency department
- •Needed emergency tube thoracostomy or surgical intervention
- •Hemodynamically unstable
- •Open and/or infected wounds in the fracture area
研究组 & 干预措施
Lidocaine
10% lidocaine spray was applied on the broken rib from a distance of 10 cm, 1-2 puffs. Each puff contains 10 mg of lidocaine.
干预措施: Lidocaine topical (Drug)
Tramadol
100 mg of tramadol hydrochloride was placed in 150 cc isotonic saline and given as a 15-minute intravenous infusion.
干预措施: Lidocaine topical (Drug)
Fentanyl
50 mcg of fentanyl citrate was given as a 15-minute intravenous infusion in 150 cc isotonic.
干预措施: Lidocaine topical (Drug)
结局指标
主要结局
Pain control
时间窗: 60th minutes.
We use Numeric rating scala.
次要结局
未报告次要终点
研究者
Ahmet Burak Erdem
M.D.
Ankara City Hospital Bilkent