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Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma (UMATH)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain Traumatic Injury | Drug: Methoxyflurane | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma |
| Actual Study Start Date : | June 7, 2019 |
| Actual Primary Completion Date : | March 11, 2020 |
| Actual Study Completion Date : | March 11, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Penthrox
Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.
|
Drug: Methoxyflurane
Pain will be treated with inhaled methoxyflurane (Penthrox®).
Other Name: Penthrox®)
|
- 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)
- Change of traumatic acute pain level between baseline and 30 minutes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline and 15, 30, 45, 60 minutes ]Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)
- Penthrox tolerance [ Time Frame: 60 minutes ]Collection of side effects
- Medical team level of satisfaction [ Time Frame: 60 minutes ]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 [ Time Frame: 60 minutes ]5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| France | |
| Emergency Medical Service, University Hospital, Tours | |
| Tours, France, 37044 | |
| Principal Investigator: | Julien CONRAS, MD | University Hospital, Tours |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 23, 2019 | ||||
| First Posted Date ICMJE | April 25, 2019 | ||||
| Last Update Posted Date | May 6, 2021 | ||||
| Actual Study Start Date ICMJE | June 7, 2019 | ||||
| Actual Primary Completion Date | March 11, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma | ||||
| Official Title ICMJE | Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: Methoxyflurane
Pain will be treated with inhaled methoxyflurane (Penthrox®).
Other Name: Penthrox®)
|
||||
| Study Arms ICMJE | Experimental: Penthrox
Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.
Intervention: Drug: Methoxyflurane
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
34 | ||||
| Original Estimated Enrollment ICMJE |
150 | ||||
| Actual Study Completion Date ICMJE | March 11, 2020 | ||||
| Actual Primary Completion Date | March 11, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03927729 | ||||
| Other Study ID Numbers ICMJE | DR190096 2019-A00259-48 ( Other Identifier: IdRCB ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | University Hospital, Tours | ||||
| Study Sponsor ICMJE | University Hospital, Tours | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Tours | ||||
| Verification Date | May 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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