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

Study Overview
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Brief Summary
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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.

Official Title
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METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation

Conditions
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Anterior Shoulder Dislocation

Intervention / Treatment
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* Device: Helmet virtual reality.
* Drug: Administration of METHOXYFLURANE
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>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<br>* 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.<br>|
| Experimental: Medical device : VR headset<br>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.<br>* Use of a  virtual reality  (VR) headset of  Pico G2  type with  HypnoVR  software and audio headset  Taotronics BH22  during all the reduction care<br>|
| Experimental: Medication : Methoxyflurane analgesia<br>Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL) | Drug: Administration of METHOXYFLURANE<br>* Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of co-antalgesics administered | Posology of co-analgesic medications administered | 3 months | 
| The duration of the procedure | Time lenght of the reduction procedure | Day 1 (day of change of anterior shoulder dislocation) | 
| The dosage of drugs used in procedural sedation | Posology of sedative drugs administered for a procedural sedation | Day 1 (day of reduction of anterior shoulder dislocation) | 
| The average length of stay in the emergency department | Average length of stay in the emergency department | 3 months | 
| Patient satisfaction | Patient satisfaction at the end of care evaluated with a questionnaire EVA | 3 months | 
| The rate of reduction-related complications | Complications related to the reduction | 3 months |