Sedation and pain control for adults with fractures and dislocations in the emergency department
Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
This project will try different sedation and pain-control methods to see which gives adults the best pain relief and satisfaction during emergency-room reductions of fractures or dislocations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Zealand Academic / other |
| Locations | 3 sites (Holbæk, Region Sjælland and 2 other locations) |
| Trial ID | NCT07314450 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults with upper or lower extremity fractures or joint dislocations who need painful reduction or casting in the emergency department. Patients receive the routine sedation or analgesia selected by their clinicians, such as systemic procedural sedation, regional nerve or hematoma blocks, or no analgesia, and outcomes are recorded. The study compares patient-reported pain relief and satisfaction, clinician satisfaction, and the occurrence of adverse events across these approaches. Data are collected at three Danish emergency departments to provide real-world evidence on which methods work best in routine care.
Who should consider this trial
Good fit: Adults aged 18 or older who present to participating emergency departments with upper or lower extremity fractures or joint dislocations requiring reduction or casting are eligible.
Not a fit: Children, patients who do not require reduction or casting, those treated outside the participating hospitals, or patients needing immediate operating-room care may not gain direct benefit from this study.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose sedation and analgesia methods that give patients better pain relief and higher satisfaction with fewer adverse events.
How similar studies have performed: Previous trials and observational studies have shown both systemic procedural sedation and regional nerve or hematoma blocks can provide effective pain control, but direct real-world comparisons across routine care settings are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Holbæk, Region Sjælland and 2 other locations
- Emergency Department, Holbæk Hospital — Holbæk, Region Sjælland, Denmark (Recruiting)
- Emergency Department, Zealand University Hospital — Køge, Region Sjælland, Denmark (Recruiting)
- Emergency Department, Odense University Hospital — Odense, Region Syddanmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Sophie Sværke, MD
- Email: Ibes@regionsjaelland.dk
- Phone: 31368854
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.