Use of Penthrox in Extra-hospital Traumatology

NCT ID: NCT03537001

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-29
• Study Completion Date: 2018-08-30

Brief 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

Pain, Acute; Trauma Injury; Pain Management

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Penthrox

Administration of Penthrox at the beginning of the management of the traumatized adult patient

Penthrox

Intervention Type: OTHER

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

Interventions

Penthrox

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

Intervention Type: OTHER

Eligibility Criteria

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)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanaa El Azhari, MD

Role: PRINCIPAL_INVESTIGATOR

sanaa.elazari@gmail.com

Locations

Emergency Medical Service, University Hospital, Tours

Tours, , France

Countries

France

Other Identifiers

2017-A01077-46

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH3-RNI17/UPETEH

Identifier Type: -

Identifier Source: org_study_id