Methoxyflurane Versus Usual Care for Non-Traumatic Pain in Emergency Departments (NCT07742007) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Methoxyflurane Versus Usual Care for Non-Traumatic Pain in Emergency Departments
France164 participantsStarted 2026-09-16
Plain-language summary
Pain is one of the most frequent patient-reported symptoms in emergency departments (EDs). Pain management could be very challenging, notably for patients that must wait in an ED waiting room. In such context, antalgic drugs that could be used are mainly oral medications with the paracetamol (acetaminophen), the non-steroidal anti-inflammatory drugs and the weak and strong opioid drugs as the main available options, depending on the degree of pain. Those commonly used painkillers, with oral administration, need a delay (approximatively 20 to 30 minutes) before the full analgesic effect could be observed. Methoxyflurane is a self-administered inhaled analgesic used for over 40 years in countries such as Australia. Methoxyflurane has a rapid onset of action, is well tolerated and is widely used for moderate to severe traumatic pain, with several trials that have investigated it efficacy in such indication. However, no data are available concerning the management of non-traumatic painful diseases. Thus, the aim of the open-label, multicenter, and two parallel-arms superiority PAIN-THROX randomized controlled trial is to assess how using self-administered inhaled Methoxyflurane could reduce the time to pain relief comparatively with oral analgesic medications for patients seeking in an ED for non-traumatic painful diseases and who could wait in an ED waiting room.
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:
* Adult ≥ 18 years
* Acute non-traumatic pain of moderate to severe intensity (VAS strictly greater than 39 mm)
* Able to independently assess their pain using a VAS and to record it independently on paper.
* Affiliated to a social security system
* Having signed informed consent
Exclusion Criteria:
* Age \< 18 years
* Contraindications to methoxyflurane as stated in the Summary of Product Characteristics:
* Hypersensitivity to the active substance or to any other fluorinated anesthetic or to any excipient.
* Malignant hyperthermia: known malignant hyperthermia or genetic predisposition.
* History of serious adverse reactions (patient or relatives) after administration of inhaled anesthetics.
* History of signs of liver injury after use of methoxyflurane or halogenated hydrocarbons.
* Clinically significant renal impairment
* Altered level of consciousness regardless of cause, including head trauma, drug or alcohol use
* Clinical evidence of cardiovascular instability
* Clinical evidence of respiratory depression
* Hemodynamically unstable patient (SBP \< 100 mmHg, DBP \< 30 mmHg)
* Patient having already received Methoxyflurane on the same day
* Patient having taken analgesic treatment prior to emergency consultation within 4 hours of admission.
* Pain ≤ 39 mm
* Pregnant, breastfeeding.
* Women of childbearing potential not using a highly effective method of contraception throughout the study. The absence o…
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
Time to Pain Reduction of at Least 30 mm on the Visual Analog Scale (VAS)
Timeframe: At Inclusion An at 3, 5, 10, 15, 20, 25, and 30-minutes post randomisation