Clinical trial NCT03537001: Use of Penthrox in Extra-hospital Traumatology
Official title: Use of Inhaled Methoxyflurane (Penthrox®) as an Analgesic in Extra-hospital Traumatology at EMS37
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Acute
Trauma Injury
Pain Management
Keywords: Methoxyflurane
Penthrox
anesthetic
analgesia
acute
traumatic
pain
prehospital setting
visual numeric scale
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by the ER at Tours hospital which correspond to the inclusion, non-inclusion \& exclusion criterias.

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?

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

Primary outcomes:
measure: Change of traumatic acute pain level between baseline and 5 minutes
timeFrame: Baseline, 5 minutes
Secondary outcomes:
measure: Change of traumatic acute pain level between baseline and 10 minutes
timeFrame: Baseline, 10 minutes
measure: Pain extinction duration
timeFrame: Baseline, 10 & 15 minutes
measure: Penthrox tolerance
timeFrame: Through study completion, an average of 30 minutes
measure: Medical team level of satisfaction
timeFrame: 30 minutes
measure: Patient level of satisfaction
timeFrame: 30 minutes
measure: Change of traumatic acute pain level between 0 and15 minutes
timeFrame: Baseline, 15 minutes
Other outcomes:
Locations:
city: Tours
country: France
facility: Emergency Medical Service, University Hospital, Tours
Study officials:
affiliation: sanaa.elazari@gmail.com
name: Sanaa El Azhari, MD
role: PRINCIPAL_INVESTIGATOR
References: