Clinical Trials Directory

Trials / Completed

CompletedNCT03537001

Use of Penthrox in Extra-hospital Traumatology

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

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
University Hospital, Tours · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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?

Detailed 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?

Conditions

Interventions

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

Timeline

Start date
2017-08-29
Primary completion
2018-08-30
Completion
2018-08-30
First posted
2018-05-25
Last updated
2019-04-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03537001. Inclusion in this directory is not an endorsement.