Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual Care.
- Who it may be relevant to
- Registry conditions: Pain, Procedural, Analgesia, Extremity Injury, Patient Satisfaction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Please refer to the full protocol.
Interventions
- Drug Usual Care
No intervention: Patients will receive usual care
Primary outcome measures
- Patient satisfaction via Numerical Rating Scale [Time frame: Immediately after the procedure]
Secondary outcome measures (4)
- Re-call of maximum pain intensity [Time frame: Immediately after the procedure]
- Patient satisfaction via Short Assessment of Patient Satisfaction [Time frame: Immediately after the procedure]
- Clinician satisfaction with analgosedation regimen [Time frame: Immediately after the procedure]
- Incidence of adverse events [Time frame: During and immediately after the procedure]
Eligibility criteria
Inclusion criteria
- Age ≥18.
- Patients with the following injuries are eligible:
- Reduction treatment of shoulder dislocation
- Reduction treatment of elbow dislocation
- Reduction treatment of distal radius fractures, application of cast
- Reduction treatment of finger fractures/dislocation
- 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
- Reduction treatment of hip dislocation
- Reduction treatment of patella dislocation
- Reduction of tibial shaft fracture, application of cast
- Reduction treatment of ankle fractures including distal tibia fracture
- Reduction treatment for toe fractures/dislocation
- 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
- 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 at the same day/hospital visit
- Pregnant or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 3 centers
- Emergency Department, Holbæk Hospital — Holbæk
- Emergency Department, Zealand University Hospital — Køge
- Emergency Department, Odense University Hospital — Odense
Identifiers
NCT: NCT07314450 · p-2025-19278 · S-20252000-95