Pain, Acute, Pain Management, Trauma Injury
Conditions
Keywords
Methoxyflurane, Penthrox, anesthetic, analgesia, acute, traumatic, pain, prehospital setting, visual numeric scale
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?
Interventions
OTHERPenthrox
Self-administration of penthrox by the patient under the supervision of a physician trained in its administration, in strict compliance with its MA.
Sponsors
University Hospital, Tours
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of traumatic acute pain level between baseline and 5 minutes | Baseline, 5 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain extinction duration | Baseline, 10 & 15 minutes | Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10) at 0, 10 & 15 minutes. |
| Penthrox tolerance | Through study completion, an average of 30 minutes | Collection of side effects |
| Change of traumatic acute pain level between baseline and 10 minutes | Baseline, 10 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). |
| Patient level of satisfaction | 30 minutes | 5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied) |
| Change of traumatic acute pain level between 0 and15 minutes | Baseline, 15 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). |
| Medical team level of satisfaction | 30 minutes | 5 grades satisfaction scale filled by the medical team 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied) |
Countries
France
Outcome results
None listed