Use of Penthrox in Extra-hospital Traumatology
- Conditions
- Pain, AcutePain ManagementTrauma Injury
- Interventions
- Other: Penthrox
- Registration Number
- NCT03537001
- Lead Sponsor
- University Hospital, Tours
- 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?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- Intravenous injection for analgesia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Penthrox Penthrox Administration of Penthrox at the beginning of the management of the traumatized adult patient
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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).
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).
Penthrox tolerance Through study completion, an average of 30 minutes Collection of side effects
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)
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)
Trial Locations
- Locations (1)
Emergency Medical Service, University Hospital, Tours
🇫🇷Tours, France