Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05821517

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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)

Follow-up

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

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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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Frequently Asked Questions

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