Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma

NCT ID: NCT03927729

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-07
• Study Completion Date: 2020-03-11

Brief Summary

Study of traumatized patients treated in emergency departments of Tours, seeking to optimize the management of trauma pain in an inpatient setting, with the opportunity to integrate inhaled methoxyflurane (Penthrox®) into the arsenal analgesics useful in the analgesic protocol of the Reception and Orientation Nurse.

Detailed Description

Intra-hospital, the prevalence of pain is major; this is variable depending on the studies, but permanently above 60%. A study conducted in 2015 in Tours Adult Emergencies showed a prevalence of pain of 66.5% with an average waiting time of 2h28 before receiving an analgesic.

The pain management protocol at the Tours emergency department includes paracetamol for a numerical evaluation scale (EN) < 3 and tramadol for an EN between 4 and 6. But these therapies have a delay of action too long or are given too late. An improvement in the management of pain in emergency is therefore necessary.

Methoxyflurane (Penthrox®) is a volatile fluoridated analgesic; it offers several benefits: fast over a long period, well tolerated, effective and without interference with other drugs. Despite a misuse in the 70s, it has been used for more than 20 years in Australia and New Zealand. It was granted marketing authorization in 2016 and has been marketed in France since 2017.

It should be noted that this analgesic treatment is already adopted in several hospitals in the region and also in the SAMU 37.

A similar study was conducted in Grenoble but on a different population. The investigators plan to highlight the interest of Penthrox® in the management of monotraumatic pains in the Adult Emergencies of Tours with the intention of modifying the antalgic protocol accordingly to the reception of emergencies.

Conditions

Pain; Traumatic Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Penthrox

Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.

Group Type: EXPERIMENTAL

Methoxyflurane

Intervention Type: DRUG

Pain will be treated with inhaled methoxyflurane (Penthrox®).

Interventions

Methoxyflurane

Pain will be treated with inhaled methoxyflurane (Penthrox®).

Intervention Type: DRUG

Other Intervention Names

Penthrox®)

Eligibility Criteria

Inclusion Criteria

• Conscious patient
• Age ≥ 18 years
• Acute pain of monotraumatic origin
• Pain > 4 on a visual numerical scale

Exclusion Criteria

• State of shock with unstable hemodynamics (PA <90/60)
• Suspected or proven trauma to the chest, abdomen or pelvis
• Serious head trauma
• Consciousness disorder with Glasgow score <15
• Patient who has already received analgesics (with the exception of paracetamol)
• Patient receiving an intravenous approach for analgesia
• Renal or hepatic disorders known
• Hypersensitivity to fluoridated anesthetics or history of malignant hyperthermia in the patient or family
• Pregnant or nursing woman
• Patient under judicial protection
• Non communicating patient or with difficulties of understanding

• 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

Julien CONRAS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

Emergency Medical Service, University Hospital, Tours

Tours, , France

Countries

France

Other Identifiers

2019-A00259-48

Identifier Type: OTHER

Identifier Source: secondary_id

DR190096

Identifier Type: -

Identifier Source: org_study_id