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

Pain Clinical Trial

— UMATH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927729
• Other study ID #: DR190096
• Secondary ID: 2019-A00259-48
• Status: Completed
• Phase: N/A
• Start date: June 7, 2019
• Est. completion date: March 11, 2020

Study information

• Verified date: May 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Intravenous injection for analgesia

Related Conditions & MeSH terms

• Pain
• Traumatic Injury
• Wounds and Injuries

Intervention

Drug:
• Methoxyflurane
Pain will be treated with inhaled methoxyflurane (Penthrox®).

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 15 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10)	baseline and 15 minutes
Secondary	Change of traumatic acute pain level between baseline and 30 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	baseline and 30 minutes
Secondary	Change of traumatic acute pain level between baseline and 45 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	baseline and 45 minutes
Secondary	Change of traumatic acute pain level between baseline and 60 minutes	Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).	baseline and 60 minutes
Secondary	Pain extinction duration	Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)	baseline and 15, 30, 45, 60 minutes
Secondary	Penthrox tolerance	Collection of side effects	60 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)	60 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)	60 minutes