Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma (UMATH)
Primary Purpose
Pain, Traumatic Injury
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Methoxyflurane
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Methoxyflurane, Penthrox, non opioid analgesia, traumatic pain, pain, antalgic protocol, emergency department
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
Exclusion Criteria:
- Intravenous injection for analgesia
Sites / Locations
- Emergency Medical Service, University Hospital, Tours
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Penthrox
Arm Description
Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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).
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).
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).
Pain extinction duration
Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)
Penthrox tolerance
Collection of side effects
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)
Patient level of satisfaction
5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03927729
Brief Title
Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
Acronym
UMATH
Official Title
Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Traumatic Injury
Keywords
Methoxyflurane, Penthrox, non opioid analgesia, traumatic pain, pain, antalgic protocol, emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Penthrox
Arm Type
Experimental
Arm Description
Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.
Intervention Type
Drug
Intervention Name(s)
Methoxyflurane
Other Intervention Name(s)
Penthrox®)
Intervention Description
Pain will be treated with inhaled methoxyflurane (Penthrox®).
Primary Outcome Measure Information:
Title
Change of traumatic acute pain level between baseline and 15 minutes
Description
Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10)
Time Frame
baseline and 15 minutes
Secondary Outcome Measure Information:
Title
Change of traumatic acute pain level between baseline and 30 minutes
Description
Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).
Time Frame
baseline and 30 minutes
Title
Change of traumatic acute pain level between baseline and 45 minutes
Description
Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).
Time Frame
baseline and 45 minutes
Title
Change of traumatic acute pain level between baseline and 60 minutes
Description
Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).
Time Frame
baseline and 60 minutes
Title
Pain extinction duration
Description
Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)
Time Frame
baseline and 15, 30, 45, 60 minutes
Title
Penthrox tolerance
Description
Collection of side effects
Time Frame
60 minutes
Title
Medical team level of satisfaction
Description
5 grades satisfaction scale filled by the medical team 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)
Time Frame
60 minutes
Title
Patient level of satisfaction
Description
5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Exclusion Criteria:
Intravenous injection for analgesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien CONRAS, MD
Organizational Affiliation
University Hospital, Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Medical Service, University Hospital, Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Learn more about this trial
Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
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