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

Centre Hospitalier Universitaire de Nice

Status and phase: Enrolling; Phase 4

Conditions: Anterior Shoulder Dislocation

Treatments: Drug: Standard of care; Drug: Administration of METHOXYFLURANE; Device: Helmet virtual reality.

Study type: Interventional

Funder types: Other

Identifiers

NCT05821517

21-AOI-11

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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,
• Previous inclusion in the same study

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Standard of care

Active Comparator group

Description:

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.

Treatment:

Drug: Standard of care

Medical device : VR headset

Experimental group

Description:

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

Treatment:

Device: Helmet virtual reality.

Medication : Methoxyflurane analgesia

Experimental group

Description:

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

Treatment:

Drug: Administration of METHOXYFLURANE