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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03927729
Acronym
UMATH
Enrollment
34
Registered
2019-04-25
Start date
2019-06-07
Completion date
2020-03-11
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Traumatic Injury

Keywords

Methoxyflurane, Penthrox, non opioid analgesia, traumatic pain, pain, antalgic protocol, emergency department

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.

Interventions

Pain will be treated with inhaled methoxyflurane (Penthrox®).

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of traumatic acute pain level between baseline and 15 minutesbaseline and 15 minutesEfficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10)

Secondary

MeasureTime frameDescription
Change of traumatic acute pain level between baseline and 45 minutesbaseline and 45 minutesEfficiency 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 60 minutesbaseline and 60 minutesEfficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).
Pain extinction durationbaseline and 15, 30, 45, 60 minutesDuration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)
Change of traumatic acute pain level between baseline and 30 minutesbaseline and 30 minutesEfficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).
Medical team level of satisfaction60 minutes5 grades satisfaction scale filled by the medical team 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)
Patient level of satisfaction60 minutes5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)
Penthrox tolerance60 minutesCollection of side effects

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026