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

NCT07314450 | Recruiting

• 2 other identifiers: p-2025-19278S-20252000-95
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Extremity Injury; Patient Satisfaction; Satisfaction, Personal; Satisfaction; Pain, Procedural; Analgesia; Upper Extremity Injury; Lower Extremity Fracture; Upper Extremity Fracture; Extremity Injuries Lower

Keywords

Emergency Department; Procedural sedation and analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Re-call of maximum pain intensity

  Immediately after the procedure

• Patient satisfaction via Short Assessment of Patient Satisfaction

  Immediately after the procedure

• Clinician satisfaction with analgosedation regimen

  Immediately after the procedure

• Incidence of adverse events

  During and immediately after the procedure

Other Outcomes (3)

• Patient satisfaction via 5-point Likert Scale

  Immediately after the procedure

• Incidence of procedural amnesia

  Immediately after the procedure

• Incidence of dissociative experience during treatment

  Immediately after the procedure

Study Arms (1)

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

Interventions

Usual Care DRUG

No intervention: Patients will receive usual care

Extremity injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent (e.g. unconscious, psychotic or dementia)
• Unwilling to participate in the study
• Already included in another clinical study at the same day/hospital visit
• Pregnant or breastfeeding

Sponsors & Collaborators

• Region Zealand: lead
• Zealand University Hospital: collaborator
• Odense University Hospital: collaborator
• Holbaek Sygehus: collaborator

Study Sites (3)

Emergency Department, Holbæk Hospital

Holbæk, Region Sjælland, 4600, Denmark

RECRUITING

Emergency Department, Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

RECRUITING

Emergency Department, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Pain, Procedural; Agnosia; Patient Satisfaction; Personal Satisfaction; Arm Injuries; Leg Injuries; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Wounds and Injuries; Disease Attributes; Pathologic Processes

Central Study Contacts

Sophie Sværke, MD

CONTACT

31368854; Ibes@regionsjaelland.dk

Ole Mathiesen, Professor

CONTACT

Omat@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 2, 2026
• Study Start: July 29, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

DK (3)