PENTHROX™ in the Canadian Emergency Department (ED) (NCT03868436) | Clinical Trial Compass
CompletedPhase 4
PENTHROX™ in the Canadian Emergency Department (ED)
Canada99 participantsStarted 2019-04-08
Plain-language summary
This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associated with trauma in the Canadian ED.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Conscious adult patients: ≥ 18 years of age
. Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as
. Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
. Patient is able to follow all study requirements and procedures and complete required questionnaires
Exclusion criteria
. Multi-level trauma
. Women of child bearing potential who are pregnant or peri partum, including labour
. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
. Clinically significant renal impairment
. A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mean pain intensity: Numerical Rating Scale
Timeframe: 20 mins from start of administration (STA) of PENTHROX™