Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
Recruiting now
Conditions studied: Pain, Procedural, Analgesia, Extremity Injury, Patient Satisfaction, Satisfaction, Personal, Satisfaction, Upper Extremity Injury, Lower Extremity Fracture, Upper Extremity Fracture, Extremity Injuries Lower
In brief
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.
Key facts
- Study ID
- NCT07314450
- Run by
- Region Zealand
- People needed
- 200
- Starts
- 2025-07-29
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-01-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18.
- 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
You may not qualify if…
- 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
Where it is running
- Emergency Department, Holbæk Hospital — Holbæk, Region Sjælland, Denmark (enrolling)
- Emergency Department, Zealand University Hospital — Køge, Region Sjælland, Denmark (enrolling)
- Emergency Department, Odense University Hospital — Odense, Region Syddanmark, Denmark (enrolling)
Full record on ClinicalTrials.gov
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