Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Patient satisfaction via Numerical Rating Scale
研究概览
简要总结
The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department.
The main questions it aims to answer are:
- Which sedation and analgesia methods provide the best patient satisfaction and pain relief?
- How do different treatment methods affect clinician satisfaction and the occurrence of adverse events?
The investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation/analgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control.
Participants will:
Be adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures.
Receive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care.
Report their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.
详细描述
Please refer to the full protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with the following injuries are eligible:
- •Reduction treatment of shoulder dislocation
- •Reduction treatment of elbow dislocation
- •Reduction treatment of distal radius fractures, application of cast
- •Reduction treatment of finger fractures/dislocation
- •Casting treatment of upper extremity fractures
- •Proximal humerus fracture, application of fixed sling
- •Humeral shaft fracture, application of Sarmiento brace
- •Supracondylar fracture, application of angled cast
- •Reduction treatment of hip dislocation
- •Reduction treatment of patella dislocation
- •Reduction of tibial shaft fracture, application of cast
- •Reduction treatment of ankle fractures including distal tibia fracture
- •Reduction treatment for toe fractures/dislocation
- •Casting treatment of lower extremity fractures
- •Distal femur fracture, application of cast/traction
- •Proximal tibia fracture, application of cast or hinged brace
- •Ankle fracture, application of walker
排除标准
- •Unable to give informed consent (e.g. unconscious, psychotic or dementia)
- •Unwilling to participate in the study
- •Prior inclusion in the study
- •Already included in another clinical study at the same day/hospital visit
- •Pregnant or breastfeeding
研究组 & 干预措施
Extremity injuries
Each department will collect data on the treatment patients with the upper and lower extremity injuries receive during reduction or stabilizing treatment (procedural sedation and/or analgesia, or no treatment).
干预措施: Usual Care (Drug)
结局指标
主要结局
Patient satisfaction via Numerical Rating Scale
时间窗: Immediately after the procedure
Patient satisfaction with the procedural sedation regimen will be assessed using the 11-point Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores will reflect a better outcome. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.
次要结局
- Re-call of maximum pain intensity(Immediately after the procedure)
- Patient satisfaction via Short Assessment of Patient Satisfaction(Immediately after the procedure)
- Clinician satisfaction with analgosedation regimen(Immediately after the procedure)
- Incidence of adverse events(During and immediately after the procedure)
研究者
Sophie Sværke
Principal Investigator
Region Zealand