Pain, AcutePhase 4NCT06392087
Prehospital Analgesia in Adults Using Inhaled Methoxyflurane Study
A Phase 4 study testing Methoxyflurane in people with Pain, Acute, run by Ottawa Hospital Research Institute.
Trial summary
This study is about a new pain relief medication called methoxyflurane. Pain from injuries, like broken bones, is a big reason people call ambulances. It's important to treat pain well because it can make people sick and slow down healing. But often, pain isn't treated enough, which can lead to more problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Methoxyflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Dec 2025
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indications for analgesia therapy:
- Patients ≥ 18 years of age (using a waiver of consent process)
- Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS)
- traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention)
- Unaltered (Glasgow Coma Scale (GCS) ≥ 14)
- Normotensive (systolic blood pressure ≥100)
Show all 14Show fewer
- Treated and transported
- Patients will be given methoxyflurane as soon as the treating paramedic has determined they meet inclusion criteria.
- Paramedics will follow the Advanced Life Support Patient Care Standards21 for all other care the patient requires (including pain directive if methoxyflurane does not control pain after 10 min).
- Contraindications listed in the ALS-PCS will be used by paramedics in providing analgesia. Within the standards paramedics are required to record vital signs every 5 minutes including verbal NPRS.
- Known renal impairment
- Known liver disease
- History of use of methoxyflurane in the last 3 months
- Allergy to methoxyflurane
Who cannot join
- Patients with the following characteristics will be excluded (based on the Health Canada Product Monograph):
- History or family history of malignant hyperthermia
- Age <18 years of age
- Pregnancy or breast-feeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane Study
This study is about a new pain relief medication called methoxyflurane. Pain from injuries, like broken bones, is a big reason people call ambulances. It's important to treat pain well because it can make people sick and slow down healing. But often, pain isn't treated enough, which can lead to more problems.
Paramedics use different drugs to manage pain, but some are hard to give and need special training and equipment. Methoxyflurane is a new option. It's a gas you breathe in through a special inhaler. It's been used in Australia and New Zealand for a long time and has shown to work quickly and safely for different kinds of pain.
This study wants to see if methoxyflurane works well for people with moderate to severe pain from injuries compared to other medicines like Advil, Tylenol and opioids. It's testing if methoxyflurane can give fast pain relief and if paramedics find it easy to use. The study will help understand if methoxyflurane could be a good option for treating pain in ambulances.
Read the detailed description
The aim of this multi-centred study is to evaluate the prehospital use of methoxyflurane in patients ≥ 18 years of age presenting with moderate to severe pain (verbal numeric pain rating scale (NPRS) ≥ 4) secondary to trauma (which is defined as a physical injury of sudden onset and severity which requires immediate medical attention) as compared to other current therapies available to paramedics (NSAIDS and Opioids).
This will be a prehospital prospective stepped-wedge open-label, non-blinded, cluster randomized trial, enrolling patients with trauma related moderate to severe pain (numerical pain rating scale ≥4). It will be composed of three phases, involving a total of seven Ontario paramedic services. Our 24-month study will consist of the three following phases: 1) a 6-month setup and training period, followed by phase 2) the stepped-wedge trial (8-months) and phase 3) a 9-month period for data analysis and knowledge dissemination.
The verbal numeric pain rating scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numeric scale. The scale is comprised of values ranging from 0 (no pain at all) to 10 (worst imaginable pain). After ethics approvals have been secured for all sites, and after the initial 4-week observation period (where paramedics will provide standard care) one paramedic service will be randomized, using a number generator which the study team will be blinded, to the intervention condition (Methoxyflurane). Additional paramedic services will subsequently be randomized, and notified one by one at 4 week intervals until all seven paramedic services have been randomized to the intervention arm. Data will be collected for all eligible patients in each paramedic service for a total duration of 8 months. The study will be conducted in seven paramedic services in Eastern Ontario and will enrol patients who have been treated by paramedics, trained and authorized in the use and administration of methoxyflurane.
Eastern Ontario comprises 35 300 km2 and has a total regional population of 1.76 million. There are eight base hospitals in Ontario that provide medical direction, leadership and advice in the provision of prehospital emergency care. The Regional Paramedic Program for Eastern Ontario (RPPEO) is the base hospital which provides oversight to the seven included paramedic services. These paramedic services are comprised of 944 paramedics (738 of which are Primary Care Paramedics and 256 who are Advanced Care Paramedics). In summary, this study will comprise seven land paramedic services, operating in a catchment area of 10 rural counties and 4 cities, with 18 acute care hospitals and 1 university hospital.
- Conditions
- Pain, Acute
- Being tested
- Methoxyflurane, Standard Care
- Keywords
- paramedic, traumatic pain, Ambulance
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrox
Patients ≥ 18 years of age (using a waiver of consent process) Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS) traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention) Unaltered (Glasgow Coma Scale (GCS) ≥ 14) Normotensive (systolic blood pressure ≥100) Treated and transported
Standard CareOther
Patients ≥ 18 years of age (using a waiver of consent process) Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS) traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention) Unaltered (Glasgow Coma Scale (GCS) ≥ 14) Normotensive (systolic blood pressure ≥100) Treated and transported
| Study group | Role | What they receive |
|---|---|---|
| Control standard care | Active comparator | The patients who meet the indications of the study trauma-related pain Moderate/Severe (>4 verbal numeric pain score), are provided current standard of care for pain (Advil or Ketorolac/Tylenol, opioids (for Advanced Care paramedics) Receives: Other: Standard Care |
| Intervention | Experimental | The patients who meet the indications of the study trauma-related pain Moderate/Severe (>4 verbal numeric pain score) and receive methoxyflurane Receives: Drug: Methoxyflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Numeric Pain Score
verbal numeric pain rating score (NPRS) initial and at 10 min, 0 referring to no pain and 10 severe pain
Measured: 10 min
Secondary outcomes (5)
Rescue Medications
(as defined by addition of any other pain medication (ketorolac or opioids (fentanyl or morphine) 10 min after methoxyflurane administration, during paramedic care)
Measured: 10 min
Transport Time
From time onscene, to hospital arrival
Measured: 8 months
Time to first analgesia
time to first administration of analgesia (NSAIDs, Opioids or methoxyflurane)
Measured: 8 months
Vital signs
vital signs (Blood pressure, Heart rate, oxygen saturation, temperature, respiratory rate, level of consciousness) (initial and at arrival to hospital) (repeat measures will be captured in data every 5 mins)
Measured: 5 min
Verbal numeric pain score during care
verbal numeric pain rating score (NPRS) initial and at 10 min, 0 referring to no pain and 10 severe pain (as transport times will vary)
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Ottawa Hospital Research InstituteThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Step Wedge Design
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392087
- Sponsor's protocol ID
- 20240319100
- Status last verified
- Jul 2024
- First submitted
- 19 Mar 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: de-identified data will be considered if requested for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane Study
- ClinicalTrials.gov ID
- NCT06392087
- Acronym / sponsor ID
- 20240319100
- Conditions
- Pain, Acute
- Keywords
- paramedic, traumatic pain, Ambulance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
This study is about a new pain relief medication called methoxyflurane. Pain from injuries, like broken bones, is a big reason people call ambulances. It's important to treat pain well because it can make people sick and slow down healing. But often, pain isn't treated enough, which can lead to more problems.
Paramedics use different drugs to manage pain, but some are hard to give and need special training and equipment. Methoxyflurane is a new option. It's a gas you breathe in through a special inhaler. It's been used in Australia and New Zealand for a long time and has shown to work quickly and safely for different kinds of pain.
This study wants to see if methoxyflurane works well for people with moderate to severe pain from injuries compared to other medicines like Advil, Tylenol and opioids. It's testing if methoxyflurane can give fast pain relief and if paramedics find it easy to use. The study will help understand if methoxyflurane could be a good option for treating pain in ambulances.
Detailed description
The aim of this multi-centred study is to evaluate the prehospital use of methoxyflurane in patients ≥ 18 years of age presenting with moderate to severe pain (verbal numeric pain rating scale (NPRS) ≥ 4) secondary to trauma (which is defined as a physical injury of sudden onset and severity which requires immediate medical attention) as compared to other current therapies available to paramedics (NSAIDS and Opioids).
This will be a prehospital prospective stepped-wedge open-label, non-blinded, cluster randomized trial, enrolling patients with trauma related moderate to severe pain (numerical pain rating scale ≥4). It will be composed of three phases, involving a total of seven Ontario paramedic services. Our 24-month study will consist of the three following phases: 1) a 6-month setup and training period, followed by phase 2) the stepped-wedge trial (8-months) and phase 3) a 9-month period for data analysis and knowledge dissemination.
The verbal numeric pain rating scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numeric scale. The scale is comprised of values ranging from 0 (no pain at all) to 10 (worst imaginable pain). After ethics approvals have been secured for all sites, and after the initial 4-week observation period (where paramedics will provide standard care) one paramedic service will be randomized, using a number generator which the study team will be blinded, to the intervention condition (Methoxyflurane). Additional paramedic services will subsequently be randomized, and notified one by one at 4 week intervals until all seven paramedic services have been randomized to the intervention arm. Data will be collected for all eligible patients in each paramedic service for a total duration of 8 months. The study will be conducted in seven paramedic services in Eastern Ontario and will enrol patients who have been treated by paramedics, trained and authorized in the use and administration of methoxyflurane.
Eastern Ontario comprises 35 300 km2 and has a total regional population of 1.76 million. There are eight base hospitals in Ontario that provide medical direction, leadership and advice in the provision of prehospital emergency care. The Regional Paramedic Program for Eastern Ontario (RPPEO) is the base hospital which provides oversight to the seven included paramedic services. These paramedic services are comprised of 944 paramedics (738 of which are Primary Care Paramedics and 256 who are Advanced Care Paramedics). In summary, this study will comprise seven land paramedic services, operating in a catchment area of 10 rural counties and 4 cities, with 18 acute care hospitals and 1 university hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Step Wedge Design
| Arm | Type | Receives |
|---|---|---|
| Control standard care | Active comparator | Other: Standard CareThe patients who meet the indications of the study trauma-related pain Moderate/Severe (>4 verbal numeric pain score), are provided current standard of care for pain (Advil or Ketorolac/Tylenol, opioids (for Advanced Care paramedics) |
| Intervention | Experimental | Drug: MethoxyfluraneThe patients who meet the indications of the study trauma-related pain Moderate/Severe (>4 verbal numeric pain score) and receive methoxyflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients ≥ 18 years of age (using a waiver of consent process)
- Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS)
- traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention)
- Unaltered (Glasgow Coma Scale (GCS) ≥ 14)
- Normotensive (systolic blood pressure ≥100)
Key exclusion criteria (4 listed)
- Patients with the following characteristics will be excluded (based on the Health Canada Product Monograph):
- History or family history of malignant hyperthermia
- Age <18 years of age
- Pregnancy or breast-feeding
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: PenthroxPatients ≥ 18 years of age (using a waiver of consent process) Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS) traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention) Unaltered (Glasgow Coma Scale (GCS) ≥ 14) Normotensive (systolic blood pressure ≥100) Treated and transported | Drug | Intervention |
| Standard CarePatients ≥ 18 years of age (using a waiver of consent process) Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS) traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention) Unaltered (Glasgow Coma Scale (GCS) ≥ 14) Normotensive (systolic blood pressure ≥100) Treated and transported | Other | Control standard care |
Primary outcome
Verbal Numeric Pain Score
Time frame: 10 min
verbal numeric pain rating score (NPRS) initial and at 10 min, 0 referring to no pain and 10 severe pain
5 secondary outcomes
Rescue Medications
Time frame: 10 min
Transport Time
Time frame: 8 months
Time to first analgesia
Time frame: 8 months
Vital signs
Time frame: 5 min
Verbal numeric pain score during care
Time frame: 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Undecided. de-identified data will be considered if requested for sharing.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methoxyflurane in people with Pain, Acute, run by Ottawa Hospital Research Institute.
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 14 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael A Austin, MD (6132970327, maustin@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Numeric Pain Score (time frame: 10 min). 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 19 Jul 2024.