NCT07314450 Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
| NCT ID | NCT07314450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Zealand |
| Condition | Pain, Procedural |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-07-29 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18. 2. Patients with the following injuries are eligible: 1. Reduction treatment of shoulder dislocation 2. Reduction treatment of elbow dislocation 3. Reduction treatment of distal radius fractures, application of cast 4. Reduction treatment of finger fractures/dislocation 5. 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 6. Reduction treatment of hip dislocation 7. Reduction treatment of patella dislocation 8. Reduction of tibial shaft fracture, application of cast 9. Reduction treatment of ankle fractures including distal tibia fracture 10. Reduction treatment for toe fractures/dislocation 11. 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 Exclusion Criteria: 1. Unable to give informed consent (e.g. unconscious, psychotic or dementia) 2. Unwilling to participate in the study 3. Prior inclusion in the study 4. Already included in another clinical study at the same day/hospital visit 5. Pregnant or breastfeeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07314450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Procedural. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07314450 currently recruiting?
Yes, NCT07314450 is actively recruiting participants. Contact the research team at Ibes@regionsjaelland.dk for enrollment information.
Where is the NCT07314450 trial being conducted?
This trial is being conducted at Holbæk, Denmark, Køge, Denmark, Odense, Denmark.
Who is sponsoring the NCT07314450 clinical trial?
NCT07314450 is sponsored by Region Zealand. The trial plans to enroll 200 participants.