Clinical trial NCT05821517: METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)
Official title: METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anterior Shoulder Dislocation
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Decrease in the rate of procedural sedation of anterior shoulder dislocation
timeFrame: Day 1 (day of reduction of anterior shoulder dislocation)
Secondary outcomes:
measure: The amount of co-antalgesics administered
timeFrame: 3 months
measure: The duration of the procedure
timeFrame: Day 1 (day of change of anterior shoulder dislocation)
measure: The dosage of drugs used in procedural sedation
timeFrame: Day 1 (day of reduction of anterior shoulder dislocation)
measure: The average length of stay in the emergency department
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 3 months
measure: The rate of reduction-related complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References: