METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
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.
|
| Experimental: Medical device : VR headset Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care |
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
|
| Experimental: Medication : Methoxyflurane analgesia Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL) |
Drug: Administration of METHOXYFLURANE
Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)
|
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- The amount of co-antalgesics administered [3 months]
Posology of co-analgesic medications administered
- The duration of the procedure [Day 1 (day of reduction of anterior shoulder dislocation)]
Time lenght of the reduction procedure
- The dosage of drugs used in procedural sedation [Day 1 (day of reduction of anterior shoulder dislocation)]
Posology of sedative drugs administered for a procedural sedation
- The average length of stay in the emergency department [3 months]
Average length of stay in the emergency department
- Patient satisfaction [3 months]
Patient satisfaction at the end of care evaluated with a questionnaire
- The rate of reduction-related complications [3 months]
Complications related to the reduction
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nice University Hospital | Nice | France | 06000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-AOI-11