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OpenTrials
Completed

NCT Number: NCT03537001

Use of Penthrox in Extra-hospital Traumatology

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Medical Service, University Hospital, Tours

Tours, 37044, France

About this study

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?

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 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

Treatment and study plan

Penthrox

Other

Self-administration of penthrox by the patient under the supervision of a physician trained in its administration, in strict compliance with its MA.

Primary outcomes

  1. Change of traumatic acute pain level between baseline and 5 minutes

    Time frame: Baseline, 5 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 10 minutes

    Time frame: Baseline, 10 minutes

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

  2. Pain extinction duration

    Time frame: Baseline, 10 & 15 minutes

    Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10) at 0, 10 & 15 minutes.

  3. Penthrox tolerance

    Time frame: Through study completion, an average of 30 minutes

    Collection of side effects

  4. Medical team level of satisfaction

    Time frame: 30 minutes

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

  5. Patient level of satisfaction

    Time frame: 30 minutes

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

  6. Change of traumatic acute pain level between 0 and15 minutes

    Time frame: Baseline, 15 minutes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Use of Inhaled Methoxyflurane (Penthrox®) as an Analgesic in Extra-hospital Traumatology at EMS37

Acronym: UPETEH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 25, 2018
Registry last updated
Apr 24, 2019

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.

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