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

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Patient Satisfaction; Pain, Procedural; Satisfaction; Extremity Injury; Upper Extremity Injury; Upper Extremity Fracture; Satisfaction, Personal; Lower Extremity Fracture; Extremity Injuries Lower
• Intervention / Treatment: Drug: Usual Care

Detailed Description

Please refer to the full protocol.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sophie Sværke, MD; Phone Number: 31368854; Email: Ibes@regionsjaelland.dk
• Study Contact Backup: Name: Ole Mathiesen, Professor; Email: Omat@regionsjaelland.dk

Study Locations

• Denmark
  • Region Sjælland
    • Holbæk, Region Sjælland, Denmark, 4600
      • Recruiting
      • Emergency Department, Holbæk Hospital
      • Contact: Anders Krusenstjerna-Hafstrøm, MD; Email: Andh@regionsjaelland.dk
      • Principal Investigator: Martin Schou, MD
      • Sub-Investigator: Anders Krusenstjerna-Hafstrøm, MD
    • Køge, Region Sjælland, Denmark, 4600
      • Recruiting
      • Emergency Department, Zealand University Hospital
      • Contact: Marie-Laure Bouchy Jacobsson; Email: majaco@regionsjaelland.dk
      • Principal Investigator: Marie-Laure Bouchy Jacobsson, MD
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Recruiting
      • Emergency Department, Odense University Hospital
      • Contact: Mikkel Brabrand, Professor; Email: mikkel.brabrand@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Eligible patients with upper and lower extremity injuries that require painful stabilizing treatment in the emergency department.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Drug: Usual Care; No intervention: Patients will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Region Zealand
• Collaborators: Odense University Hospital; Zealand University Hospital; Holbaek Sygehus

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Emergency Department; Procedural sedation and analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Disease Attributes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Pain, Procedural; Emergencies; Agnosia; Arm Injuries; Leg Injuries; Personal Satisfaction; Patient Satisfaction
• Other Study ID Numbers: p-2025-19278; S-20252000-95 (Other Identifier: The Committees on Health Research Ethics)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No