Use of Penthrox in Extra-hospital Traumatology

Pain, Acute Clinical Trial

— UPETEH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537001
• Other study ID #: RIPH3-RNI17/UPETEH
• Secondary ID: 2017-A01077-46
• Status: Completed
• Start date: August 29, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: April 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain Management
• Pain, Acute
• Trauma Injury

Intervention

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

Locations

Country	Name	City	State
France	Emergency Medical Service, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of traumatic acute pain level between baseline and 5 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	Baseline, 5 minutes
Secondary	Change of traumatic acute pain level between baseline and 10 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	Baseline, 10 minutes
Secondary	Pain extinction duration	Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10) at 0, 10 & 15 minutes.	Baseline, 10 & 15 minutes
Secondary	Penthrox tolerance	Collection of side effects	Through study completion, an average of 30 minutes
Secondary	Medical team level of satisfaction	5 grades satisfaction scale filled by the medical team 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)	30 minutes
Secondary	Patient level of satisfaction	5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)	30 minutes
Secondary	Change of traumatic acute pain level between 0 and15 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	Baseline, 15 minutes