Clinical trial NCT03927729: Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
Official title: Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Traumatic Injury
Keywords: Methoxyflurane
Penthrox
non opioid analgesia
traumatic pain
pain
antalgic protocol
emergency department
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of traumatized patients treated in emergency departments of Tours, seeking to optimize the management of trauma pain in an inpatient setting, with the opportunity to integrate inhaled methoxyflurane (Penthrox®) into the arsenal analgesics useful in the analgesic protocol of the Reception and Orientation Nurse.

Detailed description: Intra-hospital, the prevalence of pain is major; this is variable depending on the studies, but permanently above 60%. A study conducted in 2015 in Tours Adult Emergencies showed a prevalence of pain of 66.5% with an average waiting time of 2h28 before receiving an analgesic.

The pain management protocol at the Tours emergency department includes paracetamol for a numerical evaluation scale (EN) \< 3 and tramadol for an EN between 4 and 6. But these therapies have a delay of action too long or are given too late. An improvement in the management of pain in emergency is therefore necessary.

Methoxyflurane (Penthrox®) is a volatile fluoridated analgesic; it offers several benefits: fast over a long period, well tolerated, effective and without interference with other drugs. Despite a misuse in the 70s, it has been used for more than 20 years in Australia and New Zealand. It was granted marketing authorization in 2016 and has been marketed in France since 2017.

It should be noted that this analgesic treatment is already adopted in several hospitals in the region and also in the SAMU 37.

A similar study was conducted in Grenoble but on a different population. The investigators plan to highlight the interest of Penthrox® in the management of monotraumatic pains in the Adult Emergencies of Tours with the intention of modifying the antalgic protocol accordingly to the reception of emergencies.

Eligibility criteria: Inclusion Criteria:

* Conscious patient
* Age ≥ 18 years
* Acute pain of monotraumatic origin
* Pain \> 4 on a visual numerical scale

Exclusion Criteria:

* State of shock with unstable hemodynamics (PA \<90/60)
* Suspected or proven trauma to the chest, abdomen or pelvis
* Serious head trauma
* Consciousness disorder with Glasgow score \<15
* Patient who has already received analgesics (with the exception of paracetamol)
* Patient receiving an intravenous approach for analgesia
* Renal or hepatic disorders known
* Hypersensitivity to fluoridated anesthetics or history of malignant hyperthermia in the patient or family
* Pregnant or nursing woman
* Patient under judicial protection
* Non communicating patient or with difficulties of understanding

Exclusion Criteria:

* Intravenous injection for analgesia

Primary outcomes:
measure: Change of traumatic acute pain level between baseline and 15 minutes
timeFrame: baseline and 15 minutes
Secondary outcomes:
measure: Change of traumatic acute pain level between baseline and 30 minutes
timeFrame: baseline and 30 minutes
measure: Change of traumatic acute pain level between baseline and 45 minutes
timeFrame: baseline and 45 minutes
measure: Change of traumatic acute pain level between baseline and 60 minutes
timeFrame: baseline and 60 minutes
measure: Pain extinction duration
timeFrame: baseline and 15, 30, 45, 60 minutes
measure: Penthrox tolerance
timeFrame: 60 minutes
measure: Medical team level of satisfaction
timeFrame: 60 minutes
measure: Patient level of satisfaction
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Tours
country: France
facility: Emergency Medical Service, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Julien CONRAS, MD
role: PRINCIPAL_INVESTIGATOR
References: