Use of Penthrox in Extra-hospital Traumatology (UPETEH)

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

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?

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Trauma Injury; Pain Management
• Intervention / Treatment: Other: Penthrox

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?

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Emergency Medical Service, University Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated by the ER at Tours hospital which correspond to the inclusion, non-inclusion & exclusion criterias.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Penthrox; Administration of Penthrox at the beginning of the management of the traumatized adult patient	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Penthrox tolerance	Collection of side effects	Through study completion, an average of 30 minutes
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Sanaa El Azhari, MD, sanaa.elazari@gmail.com

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: pain; acute; analgesia; anesthetic; traumatic; Methoxyflurane; Penthrox; prehospital setting; visual numeric scale
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: RIPH3-RNI17/UPETEH; 2017-A01077-46 (Other Identifier: IdRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No