Actively Recruiting
METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-12-04
150
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Anterior shoulder dislocation is a common emergency condition that requires effective pain control for successful reduction. Researchers are evaluating different pain management techniques, including methoxyflurane inhalation and virtual reality headsets, compared to standard analgesic treatments. The study aims to find the best method to reduce pain and muscle tension during the shoulder reduction process, potentially avoiding the need for procedural sedation. Participants will be randomly assigned to one of three groups: standard care using paracetamol and oxygen/nitrous oxide mixture, use of a virtual reality headset with HypnoVR software during the procedure, or self-administered inhaled methoxyflurane with a maximum dose of 3 mL. Each group receives their assigned analgesic approach before and during the shoulder dislocation reduction. During the study, participants will undergo the reduction procedure while researchers monitor pain levels, procedural sedation rates, medication use, procedure duration, and patient satisfaction. Follow-up assessments up to three months will evaluate medication use, complications related to the reduction, and emergency department stay length. The study tracks immediate and longer-term outcomes to understand how these analgesic methods affect recovery and patient experience.
CONDITIONS
Brief Title
METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Able to use and understand the study devices
- No history of relevant shoulder surgery
- No associated fractures with the dislocation (except Malgaigne's notches)
- No presence of other associated trauma
- Not previously included in this study
You will not qualify if you...
- Withdrawal of voluntary informed consent
- Violation of study protocol
- Presence of a fracture associated with the dislocation (excluding Malgaigne's notches)
- Posterior, inferior, or erecta dislocation
- Initial vascular or nerve complications
- Any indication for surgical management
- Pregnant or breastfeeding women without effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 1 (day of reduction of anterior shoulder dislocation)
Participants receive one of three interventions during the reduction procedure for anterior shoulder dislocation: self-administered inhaled methoxyflurane analgesia, use of a virtual reality headset during the reduction care, or standard analgesic management including paracetamol, oxycodone if needed, and inhaled oxygen and nitrous oxide.
1 visit (in-person)
Duration - 3 months
Participants are followed for up to 3 months to assess outcomes such as amount of additional analgesics used, duration of procedure, drug dosages, length of stay in the emergency department, patient satisfaction, and rate of reduction-related complications.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 1 location
1
Nice University Hospital
Nice, France, 06000
Actively Recruiting
Research Team
H
HAMARD Fanny
R
RAPP Jocelyn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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