PainUMATHNCT03927729
Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
A study testing Methoxyflurane in people with Pain and Traumatic Injury, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Traumatic Injury
- What is being tested?
- Methoxyflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2019to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious patient
- Age ≥ 18 years
- Acute pain of monotraumatic origin
- Pain > 4 on a visual numerical scale
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Emergency Medical Service, University Hospital, Tours
Tours, 37044
About this study
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.
Read the 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
- Being tested
- Methoxyflurane
- Keywords
- Methoxyflurane, Penthrox, non opioid analgesia, traumatic pain, pain, antalgic protocol, emergency department
- Medical subject headings
- Pain, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrox®)
Pain will be treated with inhaled methoxyflurane (Penthrox®).
| Study group | Role | What they receive |
|---|---|---|
| Penthrox | Experimental | Patients with moderate to severe post-traumatic acute pain will be included in the emergency room. Receives: Drug: Methoxyflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and 15 minutes
Secondary outcomes (7)
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).
Measured: baseline and 30 minutes
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).
Measured: baseline and 45 minutes
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).
Measured: baseline and 60 minutes
Pain extinction duration
Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)
Measured: baseline and 15, 30, 45, 60 minutes
Penthrox tolerance
Collection of side effects
Measured: 60 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)
Measured: 60 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)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start7 Jun 2019
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien CONRAS, MD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927729
- Sponsor's protocol ID
- DR190096
- Other IDs
- 2019-A00259-48
- Acronym
- UMATH
- Status last verified
- May 2021
- First submitted
- 23 Apr 2019
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
- ClinicalTrials.gov ID
- NCT03927729
- Acronym / sponsor ID
- UMATH / DR190096
- Conditions
- Pain, Traumatic Injury
- Keywords
- Methoxyflurane, Penthrox, non opioid analgesia, traumatic pain, pain, antalgic protocol, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penthrox | Experimental | Drug: MethoxyfluranePatients with moderate to severe post-traumatic acute pain will be included in the emergency room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Conscious patient
- Age ≥ 18 years
- Acute pain of monotraumatic origin
- Pain > 4 on a visual numerical scale
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethoxyfluraneAlso: Penthrox®)Pain will be treated with inhaled methoxyflurane (Penthrox®). | Drug | Penthrox |
Primary outcome
Change of traumatic acute pain level between baseline and 15 minutes
Time frame: baseline and 15 minutes
Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10)
7 secondary outcomes
Change of traumatic acute pain level between baseline and 30 minutes
Time frame: baseline and 30 minutes
Change of traumatic acute pain level between baseline and 45 minutes
Time frame: baseline and 45 minutes
Change of traumatic acute pain level between baseline and 60 minutes
Time frame: baseline and 60 minutes
Pain extinction duration
Time frame: baseline and 15, 30, 45, 60 minutes
Penthrox tolerance
Time frame: 60 minutes
Medical team level of satisfaction
Time frame: 60 minutes
Patient level of satisfaction
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien CONRAS, MD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methoxyflurane in people with Pain and Traumatic Injury, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of traumatic acute pain level between baseline and 15 minutes (time frame: baseline and 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.