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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Препарат Administration of METHOXYFLURANE
  Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)
• Препарат 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.

Первичные конечные точки

• Decrease in the rate of procedural sedation of anterior shoulder dislocation [Срок оценки: Day 1 (day of reduction of anterior shoulder dislocation)]

Вторичные конечные точки (6)

• The amount of co-antalgesics administered [Срок оценки: 3 months]
• The duration of the procedure [Срок оценки: Day 1 (day of change of anterior shoulder dislocation)]
• The dosage of drugs used in procedural sedation [Срок оценки: Day 1 (day of reduction of anterior shoulder dislocation)]
• The average length of stay in the emergency department [Срок оценки: 3 months]
• Patient satisfaction [Срок оценки: 3 months]
• The rate of reduction-related complications [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Nice University Hospital — Nice

Идентификаторы

NCT: NCT05821517 · 21-AOI-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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