Pain, AcutePhase 4NCT04287803
Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study
A Phase 4 study testing Methoxyflurane in people with Pain, Acute and Trauma, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Pain is common and can contribute to both psychological and physiological effects if not treated. Currently primary care paramedics have limited selections within their pain management tool box. This contributes to inadequate pain management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Trauma
- What is being tested?
- Methoxyflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 12 Apr 2021to 1 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18 years of age
- Acute pain from traumatic injury
- numeric pain score >=4
Who cannot join
- Allergy or sensitivity to methoxyflurane
- History or family history of malignant hyperthermia
- Pregnant or breast-feeding patients
- Known renal impairment
- Known liver disease
- Methoxyflurane use within previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study
Pain is common and can contribute to both psychological and physiological effects if not treated. Currently primary care paramedics have limited selections within their pain management tool box. This contributes to inadequate pain management. Methoxyflurane is a safe, easy and effective choice in prehospital management of pain. The impact of this feasibility trial, will hope to inform the larger multi-centred trial and then support the implementation of out-of-hospital Canadian National Guidelines for prehospital pain control, enabling paramedics to provide rapid, effective prehospital pain relief to patients.
Read the detailed description
This will be a single-centred prehospital prospective observational feasibility study to evaluate the ability to perform a multicentred step wedge design trial. The feasibility outcomes will provide evidence for the development of the multicentred study and will capture clinical metrics to inform this larger study. A waver of consent will be sought from the ethics board with participation consent for paramedics understanding the risk of using a gas for analgesia. Patient >= 18 years of age with traumatic pain with a verbal score >= to 4 will be enrolled.
- Conditions
- Pain, Acute, Trauma
- Being tested
- Methoxyflurane
- Keywords
- prehospital, paramedic, ambulance, methoxyflurane, Penthrox, Penthrane
- Medical subject headings
- Acute Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrox, Penthrane
Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores >=4
| Study group | Role | What they receive |
|---|---|---|
| intervention Arm | Experimental | Methoxyflurane will be introduced and data will be captured to inform future multicentred step wedge design study. (This study is a feasibility study) Receives: Drug: Methoxyflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ethics approval for single site
Target: ,<= 3 months (90 days) from ethics submission
Measured: from ethics submission up to 90 days
Time to readiness to initiate the clinical trial
Target, <= 3 months (90 days) from ethics approval
Measured: From ethics approval up to 90 days
Evaluation of outcome data collected
Target: 100% of data captured in >90% cases
Measured: For length of study, up to 100 patients
Study protocol compliance by paramedics
Target, >= 80%
Measured: For length of study, up to 100 patients
Secondary outcomes (6)
Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes
Degree of change
Measured: For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department
Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)
If other medication are used to control pain
Measured: For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department
Transport time
Defined by departure from scene to arrival at hospital
Measured: For length of study, up to 100 patients, specifically departure scene to arrival at hospital
Time to first administration of methoxyflurane
Time from first patient contact to first inhalation of methoxyflurane
Measured: For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane
Vital signs and level of consciousness
Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS))
Measured: From patient contact to transfer of care
Adverse events post administration of methoxyflurane:
Example: any advanced airway interventions, oxygen requirement (oxygen saturations <94%), drop in blood pressure by 40% and/or <90 systolic, complaints of nausea or vomiting, malignant hyperthermia reaction).
Measured: For length of study, up to 100 patients. Specifically from patient contact to transfer of care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start12 Apr 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study to inform the multicentred prehospital prospective observational step wedge design trial
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Michael A Austin, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287803
- Sponsor's protocol ID
- 20191107100
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 2019
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data for primary and secondary outcome maybe available to share.
Publications
Austin MA, Sinclair J, Marchand J, Slatter M, Goldstein CE, De Mendonca B, Taljaard M, Vaillancourt C. Prehospital analgesia in adults using inhaled methoxyflurane: a feasibility study. Pain Manag. 2026 Oct 1:1-10. doi: 10.1080/17581869.2026.2736033. Online ahead of print.
PubMed 42817920
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study
- ClinicalTrials.gov ID
- NCT04287803
- Acronym / sponsor ID
- 20191107100
- Conditions
- Pain, Acute, Trauma
- Keywords
- prehospital, paramedic, ambulance, methoxyflurane, Penthrox, Penthrane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 27 Feb 2020 (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.
Pain is common and can contribute to both psychological and physiological effects if not treated. Currently primary care paramedics have limited selections within their pain management tool box. This contributes to inadequate pain management. Methoxyflurane is a safe, easy and effective choice in prehospital management of pain. The impact of this feasibility trial, will hope to inform the larger multi-centred trial and then support the implementation of out-of-hospital Canadian National Guidelines for prehospital pain control, enabling paramedics to provide rapid, effective prehospital pain relief to patients.
Detailed description
This will be a single-centred prehospital prospective observational feasibility study to evaluate the ability to perform a multicentred step wedge design trial. The feasibility outcomes will provide evidence for the development of the multicentred study and will capture clinical metrics to inform this larger study. A waver of consent will be sought from the ethics board with participation consent for paramedics understanding the risk of using a gas for analgesia. Patient >= 18 years of age with traumatic pain with a verbal score >= to 4 will be enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study to inform the multicentred prehospital prospective observational step wedge design trial
| Arm | Type | Receives |
|---|---|---|
| intervention Arm | Experimental | Drug: MethoxyfluraneMethoxyflurane will be introduced and data will be captured to inform future multicentred step wedge design study. (This study is a feasibility study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >=18 years of age
- Acute pain from traumatic injury
- numeric pain score >=4
Key exclusion criteria (6 listed)
- Allergy or sensitivity to methoxyflurane
- History or family history of malignant hyperthermia
- Pregnant or breast-feeding patients
- Known renal impairment
- Known liver disease
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, PenthraneMethoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores >=4 | Drug | intervention Arm |
Primary outcome
Time to ethics approval for single site
Time frame: from ethics submission up to 90 days
Target: ,<= 3 months (90 days) from ethics submission
Time to readiness to initiate the clinical trial
Time frame: From ethics approval up to 90 days
Target, <= 3 months (90 days) from ethics approval
Evaluation of outcome data collected
Time frame: For length of study, up to 100 patients
Target: 100% of data captured in >90% cases
Study protocol compliance by paramedics
Time frame: For length of study, up to 100 patients
Target, >= 80%
6 secondary outcomes
Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes
Time frame: For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department
Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)
Time frame: For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department
Transport time
Time frame: For length of study, up to 100 patients, specifically departure scene to arrival at hospital
Time to first administration of methoxyflurane
Time frame: For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane
Vital signs and level of consciousness
Time frame: From patient contact to transfer of care
Adverse events post administration of methoxyflurane:
Time frame: For length of study, up to 100 patients. Specifically from patient contact to transfer of care
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 28 Feb 2023.
- Derived from this study: PubMed 42817920Austin MA, Sinclair J, Marchand J, Slatter M, Goldstein CE, De Mendonca B, Taljaard M, Vaillancourt C. Prehospital analgesia in adults using inhaled methoxyflurane: a feasibility study. Pain Manag. 2026 Oct 1:1-10. doi: 10.1080/17581869.2026.2736033. Online ahead of print.
- Individual participant dataSharing planned: No. De-identified data for primary and secondary outcome maybe available to share.
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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.
Michael A Austin, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methoxyflurane in people with Pain, Acute and Trauma, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 3 inclusion and 6 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 28 Feb 2023. 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 Canada. 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.
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?
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?
Time to ethics approval for single site (time frame: from ethics submission up to 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04287803, which also lists 1 linked publication.
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 28 Feb 2023.