Skip to main content
OpenTrials
Completed

NCT Number: NCT03927729

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Medical Service, University Hospital, Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methoxyflurane

Drug

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

Other names: Penthrox®)

Primary outcomes

  1. Change of traumatic acute pain level between baseline and 15 minutes

    Time frame: baseline and 15 minutes

    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10)

Secondary outcomes

  1. Change of traumatic acute pain level between baseline and 30 minutes

    Time frame: baseline and 30 minutes

    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).

  2. Change of traumatic acute pain level between baseline and 45 minutes

    Time frame: baseline and 45 minutes

    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).

  3. Change of traumatic acute pain level between baseline and 60 minutes

    Time frame: baseline and 60 minutes

    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).

  4. Pain extinction duration

    Time frame: baseline and 15, 30, 45, 60 minutes

    Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)

  5. Penthrox tolerance

    Time frame: 60 minutes

    Collection of side effects

  6. Medical team level of satisfaction

    Time frame: 60 minutes

    5 grades satisfaction scale filled by the medical team 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)

  7. Patient level of satisfaction

    Time frame: 60 minutes

    5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: UMATH

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2019
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.