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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01077-46 | Other Identifier | IdRCB |
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In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.
An optimization of the management of pain in urgency is therefore still necessary.
A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.
The purpose of this study is to answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?
In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.
An optimization of the management of pain in urgency is therefore still necessary.
A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.
Methoxyflurane (Penthrox®) is a single-use inhalation non-opioid analgesic for the management of moderate to severe traumatic pain. This treatment has been used in New Zealand and Canada for over 20 years for the management of acute pain in adults and children. It was granted marketing authorization in Europe in 2016 and has been marketed in France since 2017.
The purpose of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penthrox | Administration of Penthrox at the beginning of the management of the traumatized adult patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penthrox | Other | Self-administration of penthrox by the patient under the supervision of a physician trained in its administration, in strict compliance with its MA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of traumatic acute pain level between baseline and 5 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). | Baseline, 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change of traumatic acute pain level between baseline and 10 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). | Baseline, 10 minutes |
| Pain extinction duration |
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Inclusion Criteria:
Non Inclusion Criteria:
Exclusion Criteria:
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Patients treated by the ER at Tours hospital which correspond to the inclusion, non-inclusion & exclusion criterias.
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| Name | Affiliation | Role |
|---|---|---|
| Sanaa El Azhari, MD | sanaa.elazari@gmail.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medical Service, University Hospital, Tours | Tours | 37044 | France |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000081084 | Accidental Injuries |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10) at 0, 10 & 15 minutes.
| Baseline, 10 & 15 minutes |
| Penthrox tolerance | Collection of side effects | Through study completion, an average of 30 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) | 30 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) | 30 minutes |
| Change of traumatic acute pain level between 0 and15 minutes | Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10). | Baseline, 15 minutes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |