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

Region Zealand

Status: Enrolling

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

Treatments: Drug: Usual Care

Study type: Observational

Funder types: Other

Identifiers

NCT07314450

S-20252000-95 (Other Identifier)

p-2025-19278

Details and patient eligibility

About

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.

Full description

Please refer to the full protocol.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Extremity injuries

Description:

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).

Treatment:

Drug: Usual Care