METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Helmet virtual reality., Administration of METHOXYFLURANE, Standard of care.
- Who it may be relevant to
- Registry conditions: Anterior Shoulder Dislocation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation
Overview
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.
Interventions
- Device Helmet virtual reality.
Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care - Drug Administration of METHOXYFLURANE
Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL) - Drug Standard of care
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.
Primary outcome measures
- Decrease in the rate of procedural sedation of anterior shoulder dislocation [Time frame: Day 1 (day of reduction of anterior shoulder dislocation)]
Secondary outcome measures (6)
- The amount of co-antalgesics administered [Time frame: 3 months]
- The duration of the procedure [Time frame: Day 1 (day of change of anterior shoulder dislocation)]
- The dosage of drugs used in procedural sedation [Time frame: Day 1 (day of reduction of anterior shoulder dislocation)]
- The average length of stay in the emergency department [Time frame: 3 months]
- Patient satisfaction [Time frame: 3 months]
- The rate of reduction-related complications [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Nice University Hospital — Nice
Identifiers
NCT: NCT05821517 · 21-AOI-11