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| ID | Type | Description | Link |
|---|---|---|---|
| S-20252000-95 | Other Identifier | The Committees on Health Research Ethics |
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| Name | Class |
|---|---|
| Zealand University Hospital | OTHER |
| Odense University Hospital | OTHER |
| Holbaek Sygehus | OTHER |
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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:
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.
Please refer to the full protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extremity injuries | Each department will collect data on the treatment patients with the upper and lower extremity injuries receive during reduction or stabilizing treatment (procedural sedation and/or analgesia, or no treatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Drug | No intervention: Patients will receive usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction via Numerical Rating Scale | Patient satisfaction with the procedural sedation regimen will be assessed using the 11-point Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores will reflect a better outcome. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed. | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Re-call of maximum pain intensity | Re-call of the maximum pain intensity during the treatment procedure will be assessed using the Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores will reflect a worse outcome. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction via 5-point Likert Scale | Patient satisfaction with the sedation regimen and treatment will be assessed using a 5-point Likert Scale, which ranges from 1 to 5, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores will reflect a better outcome. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed. |
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
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
Exclusion Criteria:
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Eligible patients with upper and lower extremity injuries that require painful stabilizing treatment in the emergency department.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Sværke, MD | Contact | 31368854 | Ibes@regionsjaelland.dk | |
| Ole Mathiesen, Professor | Contact | Omat@regionsjaelland.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department, Holbæk Hospital | Recruiting | Holbæk | Region Sjælland | 4600 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2025 |
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| Immediately after the procedure |
| Patient satisfaction via Short Assessment of Patient Satisfaction | Patient satisfaction with the sedation regimen and treatment will be assessed using the Short Assessment of Patient Satisfaction, which consists of 7 items, each scored from 0 to 4, yielding a total score ranging from 0 to 28, with the overall score reflecting a continuum from very dissatisfied to very satisfied. Higher scores will indicate greater patient satisfaction. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed. | Immediately after the procedure |
| Clinician satisfaction with analgosedation regimen | Clinician satisfaction with the analgosedation regimen will be assessed using the Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores will reflect a better outcome. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed. | Immediately after the procedure |
| Incidence of adverse events | Incidence of the following adverse events will be recorded: hypoxia, hypotension, treatment-requiring bradycardia, nausea, vomiting, hallucinations, and the need for reversal agents (antidote medication). Each event will be reported as a dichotomous outcome (present or absent). Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed. | During and immediately after the procedure |
| Immediately after the procedure |
| Incidence of procedural amnesia | Incidence of procedural amnesia will be assessed as a patient-reported outcome. Each case will be recorded as present or absent. Higher incidence reflects a better outcome. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed. | Immediately after the procedure |
| Incidence of dissociative experience during treatment | Incidence of dissociative experience during the treatment procedure will be assessed as a patient- and physician-reported outcome. Each case will be recorded as present or absent and categorized as a good or bad experience. A higher incidence of bad experiences will reflect a worse outcome, whereas a higher incidence of good experiences will reflect a better outcome. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed. | Immediately after the procedure |
| Emergency Department, Zealand University Hospital | Recruiting | Køge | Region Sjælland | 4600 | Denmark |
|
| Emergency Department, Odense University Hospital | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
|
| Oct 14, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D000377 | Agnosia |
| D017060 | Patient Satisfaction |
| D010549 | Personal Satisfaction |
| D001134 | Arm Injuries |
| D007869 | Leg Injuries |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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