METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)

NCT05821517 | Recruiting Phase 4

• 1 other identifier: 21-AOI-11
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Anterior shoulder dislocation is a pathology frequently encountered in emergency medicine. The success in reducing anterior shoulder dislocations depends on muscle relaxation, which is itself conditioned by the patient's pain and apprehension. However, there is no consensus on the optimal technique for reducing anterior shoulder dislocation or the analgesia associated with it. Analgesia with METHOXYFLURANE showed a greater reduction in post-traumatic pain compared to standard analgesic treatment and faster action of METHOXYFLURANE. A retrospective study which has compared analgesia with METHOXYFLURANE and analgesic sedation with PROPOFOL found a shoulder reduction success rate of 80% and a reduction in the average length of stay in the emergency department. Finally, the use of virtual reality in pain management is emerging in our practices by allowing pre- and per-procedure hypno-sedation-analgesia. However, the use of virtual reality headsets has not been studied in the management of anterior shoulder dislocation. The use of these two techniques could therefore limit the use of procedural sedation in the context of shoulder dislocation reduction.

Conditions

Anterior Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• Decrease in the rate of procedural sedation of anterior shoulder dislocation

  Rate of use of procedural sedation for anterior shoulder dislocation reduction in the interventional groups compared to the control group

  Day 1 (day of reduction of anterior shoulder dislocation)

Secondary Outcomes (6)

• The amount of co-antalgesics administered

  3 months

• The duration of the procedure

  Day 1 (day of change of anterior shoulder dislocation)

• The dosage of drugs used in procedural sedation

  Day 1 (day of reduction of anterior shoulder dislocation)

• The average length of stay in the emergency department

  3 months

• Patient satisfaction

  3 months

Study Arms (3)

Standard of care

ACTIVE COMPARATOR

An anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure.

Drug: Standard of care

Medical device : VR headset

EXPERIMENTAL

Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care

Device: Helmet virtual reality.

Medication : Methoxyflurane analgesia

EXPERIMENTAL

Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)

Drug: Administration of METHOXYFLURANE

Interventions

Helmet virtual reality. DEVICE

Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care

Medical device : VR headset

Administration of METHOXYFLURANE DRUG

Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)

Medication : Methoxyflurane analgesia

Standard of care DRUG

An anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure.

Standard of care

Eligibility Criteria

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

You may qualify if:

• Pregnant and/or breastfeeding women and women of childbearing age who do not have effective contraception (hormonal, mechanical or surgical).
• Patients with difficulties in understanding or using the devices studied.
• Patients with a contraindication to the use of one of the studied devices.
• Patients with a history of relevant shoulder surgery
• Presence of other associated trauma,

You may not qualify if:

• Withdrawal of voluntary informed consent from the patient
• Violation of protocol
• Presence of a fracture associated with the dislocation (excluding Malgaigne's notches)
• Posterior, inferior or erecta dislocation
• Presence of initial vascular and nerve complications
• Any indication for surgical management

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

HAMARD Fanny

CONTACT

04 92 03 85 81; hamard.f@chu-nice.fr

RAPP Jocelyn

CONTACT

04 92 03 85 35; rapp.j@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 20, 2023
• Study Start: December 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)