Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT03256903
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03256903
Study Brief:
Protocol Section:
NCT03256903