Actively Recruiting

Age: 18Years +
All Genders
NCT07314450

Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department

Led by Region Zealand · Updated on 2026-01-02

200

Participants Needed

3

Research Sites

48 weeks

Total Duration

On this page

Sponsors

R

Region Zealand

Lead Sponsor

Z

Zealand University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Reduction treatment of shoulder dislocation
  • Reduction treatment of elbow dislocation
  • Reduction treatment of distal radius fractures with cast application
  • Reduction treatment of finger fractures or dislocations
  • Casting treatment of upper extremity fractures including proximal humerus fracture with fixed sling, humeral shaft fracture with Sarmiento brace, and supracondylar fracture with angled cast
  • Reduction treatment of hip dislocation
  • Reduction treatment of patella dislocation
  • Reduction of tibial shaft fracture with cast application
  • Reduction treatment of ankle fractures including distal tibia fracture
  • Reduction treatment of toe fractures or dislocations
  • Casting treatment of lower extremity fractures including distal femur fracture with cast or traction, proximal tibia fracture with cast or hinged brace, and ankle fracture with walker
Not Eligible

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

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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

Actively Recruiting

3

Emergency Department, Odense University Hospital

Odense, Region Syddanmark, Denmark, 5000

Actively Recruiting

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Research Team

S

Sophie Sværke, MD

CONTACT

O

Ole Mathiesen, Professor

CONTACT

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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