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Use of Penthrox in Extra-hospital Traumatology (UPETEH)

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Trauma Injury
Pain Management
Pain, Acute

Treatments

Other: Penthrox

Study type

Observational

Funder types

Other

Identifiers

NCT03537001
2017-A01077-46 (Other Identifier)
RIPH3-RNI17/UPETEH

Details and patient eligibility

About

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?

Full description

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?

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Penthrox
Description:
Administration of Penthrox at the beginning of the management of the traumatized adult patient
Treatment:
Other: Penthrox

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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