Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma (UMATH)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Traumatic Injury
• Intervention / Treatment: Drug: Methoxyflurane

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Emergency Medical Service, University Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Penthrox; Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.	Drug: Methoxyflurane; Pain will be treated with inhaled methoxyflurane (Penthrox®).; Other Names: Penthrox®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of traumatic acute pain level between baseline and 15 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10)	baseline and 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of traumatic acute pain level between baseline and 30 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	baseline and 30 minutes
Change of traumatic acute pain level between baseline and 45 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	baseline and 45 minutes
Change of traumatic acute pain level between baseline and 60 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	baseline and 60 minutes
Pain extinction duration	Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)	baseline and 15, 30, 45, 60 minutes
Penthrox tolerance	Collection of side effects	60 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)	60 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)	60 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Julien CONRAS, MD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2019
• Primary Completion (ACTUAL): March 11, 2020
• Study Completion (ACTUAL): March 11, 2020

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (ACTUAL): April 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pain; emergency department; Methoxyflurane; Penthrox; traumatic pain; non opioid analgesia; antalgic protocol
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Methoxyflurane
• Other Study ID Numbers: DR190096; 2019-A00259-48 (OTHER: IdRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No