drugset / Trial / NCT05821517

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

NCT05821517

Phase 4 Recruiting 150 enrolled Centre Hospitalier Universitaire de Nice
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-12-30
Primary completion
2026-12-30
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 1 g
Comparator MEOPA Unknown Inhaled
Subject Methoxyflurane Small molecule 3 ml Inhaled
Comparator Oxycodone Other / unclassified 5 mg
Comparator Oxycodone Other / unclassified 10 mg

Indications

No indication recorded.