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NCT Number: NCT07314450

Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department

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.

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Key information

Conditions

Pain, Procedural Agnosia Analgesia Arm Injuries Behavior Disease Attributes Emergencies Extremity Injuries Lower Extremity Injury Health Behavior Leg Injuries Lower Extremity Fracture Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Personal Satisfaction Satisfaction Satisfaction, Personal Signs and Symptoms Treatment Adherence and Compliance Upper Extremity Fracture Upper Extremity Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Department, Holbæk Hospital, Holbæk, Region Sjælland, Denmark

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About this study

Please refer to the full protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Drug

No intervention: Patients will receive usual care

Primary outcomes

  1. Patient satisfaction via Numerical Rating Scale

    Time frame: Immediately after the procedure

    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.

Secondary outcomes

  1. Re-call of maximum pain intensity

    Time frame: Immediately after the procedure

    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.

  2. Patient satisfaction via Short Assessment of Patient Satisfaction

    Time frame: Immediately after the procedure

    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.

  3. Clinician satisfaction with analgosedation regimen

    Time frame: Immediately after the procedure

    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.

  4. Incidence of adverse events

    Time frame: During and immediately after the procedure

    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.

Other outcomes

  1. Patient satisfaction via 5-point Likert Scale

    Time frame: Immediately after the procedure

    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.

  2. Incidence of procedural amnesia

    Time frame: Immediately after the procedure

    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.

  3. Incidence of dissociative experience during treatment

    Time frame: Immediately after the procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ole Mathiesen, Professor

CONTACT

[email protected]

Sophie Sværke, MD

CONTACT

[email protected]

31368854

Sponsors and collaborators

Lead sponsor

Region Zealand

Other

Collaborators

  • Holbaek Sygehus
  • Odense University Hospital
  • Zealand University Hospital

Registry information

Acronym: PAINEX

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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