Clinical Trial

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

Study acronym: PAINEX
Recruiting
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Record status
This record was last updated January 2, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07314450
Lead Sponsor Region Zealand
Collaborators: Zealand University Hospital, Odense University Hospital, Holbaek Sygehus
Conditions Pain, Procedural, Analgesia, Extremity Injury, Patient Satisfaction, Satisfaction, Personal, Satisfaction, Upper Extremity Injury, Lower Extremity Fracture +2 more
Enrollment 200 participants
Start Date 2025-07-29
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-02