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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Administration of METHOXYFLURANE

    Drug

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

  • 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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Standard of careActive comparator 1 intervention
Group B: Medical device : VR headsetExperimental treatment 1 intervention
Group C: Medication : Methoxyflurane analgesiaExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Day 1 (day of reduction of anterior shoulder dislocation)

Secondary outcomes

1

The amount of co-antalgesics administered

Posology of co-analgesic medications administered

Time frame
3 months
2

The duration of the procedure

Time lenght of the reduction procedure

Time frame
Day 1 (day of change of anterior shoulder dislocation)
3

The dosage of drugs used in procedural sedation

Posology of sedative drugs administered for a procedural sedation

Time frame
Day 1 (day of reduction of anterior shoulder dislocation)
4

The average length of stay in the emergency department

Average length of stay in the emergency department

Time frame
3 months

Other outcomes

Sponsors and contacts

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