Pain, AcuteUPETEHNCT03537001
Use of Penthrox in Extra-hospital Traumatology
An observational study of Pain, Acute and Trauma Injury, run by University Hospital, Tours at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Trauma Injury, Pain Management
- What is being tested?
- Penthrox
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2017to 30 Aug 2018
- Phase
- Observational
- 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
Study population: Patients treated by the ER at Tours hospital which correspond to the inclusion, non-inclusion \& exclusion criterias.
Who may be able to join
- Conscious Patient
- Age ≥ 18 years
- Acute pain only of traumatic origin
- Pain > 4 on a visual numerical scale (VNS)
- Stable hemodynamic conditions (PA> 90/60)
- Non Inclusion Criteria:
Show all 13Show fewer
- Pregnant or nursing woman
- Patient who has already received analgesics
- Patient benefiting from an intravenous approach for analgesia
- Known renal or hepatic disease
- Hypersensitivity to fluorinated anesthetics or history of malignant hyperthermia of the patient or family.
- Respiratory distress
- Patient who objected to the processing of his data
Who cannot join
- 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
Official title: Use of Inhaled Methoxyflurane (Penthrox®) as an Analgesic in Extra-hospital Traumatology at EMS37
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?
Read the detailed description
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:
- To study the efficacy and safety of Penthrox, administrated at the beginning of the management of the traumatized adult patient.
- Assess the comfort of patients and caregivers
- 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?
- Conditions
- Pain, Acute, Trauma Injury, Pain Management
- Being tested
- Penthrox
- Keywords
- Methoxyflurane, Penthrox, anesthetic, analgesia, acute, traumatic, pain, prehospital setting, visual numeric scale
- Medical subject headings
- Acute Pain, Accidental Injuries, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PenthroxOther
Self-administration of penthrox by the patient under the supervision of a physician trained in its administration, in strict compliance with its MA.
| Study group | Role | What they receive |
|---|---|---|
| Penthrox | Administration of Penthrox at the beginning of the management of the traumatized adult patient Receives: Other: Penthrox |
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 5 minutes
Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).
Measured: Baseline, 5 minutes
Secondary outcomes (6)
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).
Measured: Baseline, 10 minutes
Pain extinction duration
Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10) at 0, 10 \& 15 minutes.
Measured: Baseline, 10 & 15 minutes
Penthrox tolerance
Collection of side effects
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Baseline, 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start29 Aug 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanaa El Azhari, MD, Principal investigator, sanaa.elazari@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537001
- Sponsor's protocol ID
- RIPH3-RNI17/UPETEH
- Other IDs
- 2017-A01077-46
- Acronym
- UPETEH
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2018
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Inhaled Methoxyflurane (Penthrox®) as an Analgesic in Extra-hospital Traumatology at EMS37
- ClinicalTrials.gov ID
- NCT03537001
- Acronym / sponsor ID
- UPETEH / RIPH3-RNI17/UPETEH
- Conditions
- Pain, Acute, Trauma Injury, Pain Management
- Keywords
- Methoxyflurane, Penthrox, anesthetic, analgesia, acute, traumatic, pain, prehospital setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 25 May 2018 (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.
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?
Detailed description
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:
- To study the efficacy and safety of Penthrox, administrated at the beginning of the management of the traumatized adult patient.
- Assess the comfort of patients and caregivers
- 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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penthrox | – | Other: PenthroxAdministration of Penthrox at the beginning of the management of the traumatized adult patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by the ER at Tours hospital which correspond to the inclusion, non-inclusion \& exclusion criterias.
Key inclusion criteria (13 listed)
- Conscious Patient
- Age ≥ 18 years
- Acute pain only of traumatic origin
- Pain > 4 on a visual numerical scale (VNS)
- Stable hemodynamic conditions (PA> 90/60)
Key exclusion criteria (1 listed)
- Intravenous injection for analgesia
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 |
|---|---|---|
| PenthroxSelf-administration of penthrox by the patient under the supervision of a physician trained in its administration, in strict compliance with its MA. | Other | Penthrox |
Primary outcome
Change of traumatic acute pain level between baseline and 5 minutes
Time frame: Baseline, 5 minutes
Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).
6 secondary outcomes
Change of traumatic acute pain level between baseline and 10 minutes
Time frame: Baseline, 10 minutes
Pain extinction duration
Time frame: Baseline, 10 & 15 minutes
Penthrox tolerance
Time frame: Through study completion, an average of 30 minutes
Medical team level of satisfaction
Time frame: 30 minutes
Patient level of satisfaction
Time frame: 30 minutes
Change of traumatic acute pain level between 0 and15 minutes
Time frame: Baseline, 15 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 24 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Sanaa El Azhari, MD principal investigator
sanaa.elazari@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Acute and Trauma 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 13 inclusion and 1 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 24 Apr 2019. 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 5 minutes (time frame: Baseline, 5 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 24 Apr 2019.