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

StatusRecruiting
PhasePhase 4
Started2023-12-30
View on ClinicalTrials.gov ↗

Amendment history

2025-11-27
minor
Study Status v3
Primary completion date2024-11-01→2026-12-30
Completion date2025-02-01→2027-03
Start date2023-05-01→2023-12-30
2024-06-03
minor
Study Status v2
Re-verified, no change to tracked fields
2023-09-05
notable
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Secondary endpointsdetails revised at 2 of 6 entries
Study sitesdetails revised at 1 of 1 site
2023-04-18
minor
Original filing
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.
Trial Details
NCT Number NCT05821517
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions Anterior Shoulder Dislocation
Enrollment 150 participants
Start Date 2023-12-30
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-04