An observational study in Pain, Procedural, Analgesia and Extremity Injury, sponsored by Region Zealand. Recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Region Zealand · Observational
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 13 observational studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Region Zealand is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible patients with upper and lower extremity injuries that require painful stabilizing treatment in the emergency department.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with the following injuries are eligible:
Casting treatment of upper extremity fractures
Casting treatment of lower extremity fractures
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Usual Care
No intervention: Patients will receive usual care
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.
Time frame: Immediately after the procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During and immediately after the procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after the procedure
PDFs hosted by the registry, ClinicalTrials.gov.
Started Jul 2025 (actual). Primary completion is estimated for Jul 2026, 11 months after the start.
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