Ireland
--:--IST
Recruiting Phase 4

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

NCT05821517 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2023-12-30
Last updated
2025-12-04

Condition(s) studied

Anterior Shoulder Dislocation

Investigational drug(s) / intervention(s)

Helmet virtual reality.Administration of METHOXYFLURANEStandard of care

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

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Decrease in the rate of procedural sedation of anterior shoulder dislocation — Day 1 (day of reduction of anterior shoulder dislocation)
    Rate of use of procedural sedation for anterior shoulder dislocation reduction in the interventional groups compared to the control group

Trial sites (1)

FacilityCityRegionStatus
Nice University Hospital Nice France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05821517 on ClinicalTrials.gov ↗ ← All trials in France