Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units (NCT03256903) | Clinical Trial Compass
CompletedPhase 3
Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units
Spain310 participantsStarted 2017-07-07
Plain-language summary
Clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used in usual clinical practice, in patients with trauma and associated pain, treated in Spanish emergency units.
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 patients: ≥ 18 years of age
* Moderate to severe pain (NRS 0-10; \>=4) secondary to trauma
* Without anticipating surgery due to the trauma, requiring hospitalization (hospital stay 12h)
* Conscious patient.
* Giving informed consent in writing
Exclusion Criteria:
* Hypersensitivity to methoxyflurane (MEOF) or any fluorinated anaesthetic.
* Malignant hyperthermia: patients with known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
* Patients who have a history of showing signs of liver damage after previous MEOF use or halogenated hydrocarbon anaesthesia
* Known clinically significant renal impairment
* Known pregnant or likely to be pregnant women at the time of inclusion.
* Clinically evident cardiovascular instability
* Clinically evident respiratory depression
* Patients taken any analgesic for the traumatic pain before inclusion
* Altered level of consciousness due to any cause, including head injury, drugs or alcohol
* Degenerative diseases, mental illness or other conditions that could affect ability of valuing pain intensity
* Patients to be unable to understand the purpose of the study and perform self-assessments, following investigator's criteria.
* Participation in another clinical trial within 30 days prior to randomization
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
Pain relief
Timeframe: At baseline, 3, 5, 10, 15 and 20 minutes from STA
2
Analgesia effectiveness
Timeframe: Change from baseline to 3, 5, 10, 15, 20 and 30 min
3
Analgesia speed of action
Timeframe: From time of randomization up to 20 minutes
4
Safety for patients with severe pain, treated with second or third step analgesics
Timeframe: Up until 14 days from STA
5
Patient-averaged summed pain intensity difference 15 min after STA
Timeframe: from baseline to 3, 5, 10 and 15 minutes post dose