Use of Penthrox in Extra-hospital Traumatology

Study Overview
=================
Brief Summary
-----------------
In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal. An optimization of the management of pain in urgency is therefore still necessary. A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use. The purpose of this study is to answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?

Detailed Description
-----------------
In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal. An optimization of the management of pain in urgency is therefore still necessary. A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use. Methoxyflurane (Penthrox®) is a single-use inhalation non-opioid analgesic for the management of moderate to severe traumatic pain. This treatment has been used in New Zealand and Canada for over 20 years for the management of acute pain in adults and children. It was granted marketing authorization in Europe in 2016 and has been marketed in France since 2017. The purpose of this study is: To study the efficacy and safety of Penthrox, administrated at the beginning of the management of the traumatized adult patient. Assess the comfort of patients and caregivers To answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?

Official Title
-----------------
Use of Inhaled Methoxyflurane (Penthrox®) as an Analgesic in Extra-hospital Traumatology at EMS37

Conditions
-----------------
Pain, Acute, Trauma Injury, Pain Management

Intervention / Treatment
-----------------
* Other: Penthrox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Conscious Patient Age ≥ 18 years Acute pain only of traumatic origin Pain > 4 on a visual numerical scale (VNS) Stable hemodynamic conditions (PA> 90/60) Non Inclusion Criteria: Pregnant or nursing woman Patient who has already received analgesics Patient benefiting from an intravenous approach for analgesia Known renal or hepatic disease Hypersensitivity to fluorinated anesthetics or history of malignant hyperthermia of the patient or family. Respiratory distress Patient who objected to the processing of his data Exclusion Criteria: Intravenous injection for analgesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Penthrox<br>Administration of Penthrox at the beginning of the management of the traumatized adult patient | Other: Penthrox<br>* Self-administration of penthrox by the patient under the supervision of a physician trained in its administration, in strict compliance with its MA.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of traumatic acute pain level between baseline and 5 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). | Baseline, 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of traumatic acute pain level between baseline and 10 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). | Baseline, 10 minutes | 
| Pain extinction duration | Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10) at 0, 10 & 15 minutes. | Baseline, 10 & 15 minutes | 
| Penthrox tolerance | Collection of side effects | Through study completion, an average of 30 minutes | 
| Medical team level of satisfaction | 5 grades satisfaction scale filled by the medical team 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied) | 30 minutes | 
| Patient level of satisfaction | 5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied) | 30 minutes | 
| Change of traumatic acute pain level between 0 and15 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). | Baseline, 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methoxyflurane, Penthrox, anesthetic, analgesia, acute, traumatic, pain, prehospital setting, visual numeric scale