Actively Recruiting
Procedural Sedation and Analgesia for Adults With Fractures and Dislocations in the Emergency Department
Led by Region Zealand · Updated on 2026-01-02
200
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Region Zealand
Lead Sponsor
Z
Zealand University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different sedation and pain relief methods used during treatment of adults with painful fractures and dislocations in the emergency department. The study aims to find out which procedural sedation and analgesia approaches provide the best patient satisfaction and pain control, as well as how these methods impact clinician satisfaction and the occurrence of side effects. This observational study follows guidelines for careful data collection and comparison across several hospitals. Participants will receive one of the usual sedation or analgesia treatments or no analgesia during their emergency care for upper or lower extremity injuries needing painful reduction or casting procedures. Data will be collected about the treatment given, including systemic sedation or regional techniques like nerve or hematoma blocks. Each hospital will gather information on the care given during the reduction or stabilization procedures. During the study, adult patients will report their pain levels and satisfaction before, during, and after the treatment. Researchers will monitor for any side effects, complications, or need for antidotes. The main outcome measured is patient satisfaction immediately after the procedure using a numerical rating scale. Additional outcomes include recalled maximum pain, clinician satisfaction, and adverse events during and after treatment. The data collection period will last six months, involving multiple hospital sites.
CONDITIONS
Brief Title
Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients undergoing reduction treatment for shoulder dislocation
- Patients undergoing reduction treatment for elbow dislocation
- Patients undergoing reduction or casting treatment for distal radius fractures
- Patients undergoing reduction treatment for finger fractures or dislocations
- Patients receiving casting treatment for upper extremity fractures including proximal humerus, humeral shaft, and supracondylar fractures
- Patients undergoing reduction treatment for hip dislocation
- Patients undergoing reduction treatment for patella dislocation
- Patients undergoing reduction or casting treatment for tibial shaft, ankle, distal femur, proximal tibia, and toe fractures or dislocations
- Patients receiving casting or brace treatment for lower extremity fractures such as distal femur, proximal tibia, and ankle fractures
You will not qualify if you...
- 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 on the same day or hospital visit
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the procedure and immediate post-procedure period
Participants who undergo routine care are observed during and immediately after their treatment for fractures and dislocations in the emergency department.
1 visit (in-person) during treatment
Trial Site Locations
Total: 3 locations
1
Emergency Department, Holbæk Hospital
Holbæk, Region Sjælland, Denmark, 4600
Actively Recruiting
2
Emergency Department, Zealand University Hospital
Køge, Region Sjælland, Denmark, 4600
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3
Emergency Department, Odense University Hospital
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
Research Team
S
Sophie Sværke, MD
O
Ole Mathiesen, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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