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Methoxyflurane versus Standard Care for Non-Traumatic Pain in the Emergency Department (PAIN-THROX) : A Multicenter, Randomized, Controlled, Superiority Trial
EU CTIS ID: 2025-525001-21-00
What this study is testing
The primary objective is to demonstrate the superiority of methoxyflurane in achieving rapid effective analgesia compared with standard pain management based on oral analgesics, in the emergency department waiting room, in adult patients presenting with non-traumatic painful conditions.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult ≥ 18 years
- Moderate to severe acute non-traumatic pain (VAS strictly greater than 39 mm)
- Able to self-assess pain using a VAS and to independently record this on a paper form
- Affiliated with a social security system
- Has provided written informed consent
You likely can't join if
- Age < 18 years
- Patients currently within the exclusion period of another clinical trial.
- Contraindications to methoxyflurane as described in the Summary of Product Characteristics (SmPC): o Hypersensitivity to the active substance, to any fluorinated anesthetic, or to any excipient listed in section 6.1 of the SmPC o Malignant hyperthermia: known history or genetic predisposition o History of serious adverse reactions (in the patient or relatives) following administration of inhaled anesthetics o History of signs of liver injury following methoxyflurane use or anesthesia with halogenated hydrocarbons o Clinically significant renal impairment o Altered level of consciousness from any cause, including head injury, drug or alcohol use o Clinical evidence of cardiovascular instability o Clinical evidence of respiratory depression
- Hemodynamically unstable patient (SBP < 100 mmHg, DBP < 30 mmHg)
- Patient who has already received methoxyflurane on the same day
- Patient who has taken analgesic treatment prior to emergency department consultation within 4 hours of admission.
See the full eligibility criteria
- Adult ≥ 18 years
- Moderate to severe acute non-traumatic pain (VAS strictly greater than 39 mm)
- Able to self-assess pain using a VAS and to independently record this on a paper form
- Affiliated with a social security system
- Has provided written informed consent
- Age < 18 years
- Patients currently within the exclusion period of another clinical trial.
- Contraindications to methoxyflurane as described in the Summary of Product Characteristics (SmPC): o Hypersensitivity to the active substance, to any fluorinated anesthetic, or to any excipient listed in section 6.1 of the SmPC o Malignant hyperthermia: known history or genetic predisposition o History of serious adverse reactions (in the patient or relatives) following administration of inhaled anesthetics o History of signs of liver injury following methoxyflurane use or anesthesia with halogenated hydrocarbons o Clinically significant renal impairment o Altered level of consciousness from any cause, including head injury, drug or alcohol use o Clinical evidence of cardiovascular instability o Clinical evidence of respiratory depression
- Hemodynamically unstable patient (SBP < 100 mmHg, DBP < 30 mmHg)
- Patient who has already received methoxyflurane on the same day
- Patient who has taken analgesic treatment prior to emergency department consultation within 4 hours of admission.
- Pain ≤ 39 mm
- Pregnant or breastfeeding women
- Individuals under legal protection (guardianship, curatorship, or judicial protection)
- Women of childbearing potential not using a highly effective method of contraception throughout the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.