Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units (InMEDIATE)
Acute Pain Due to Trauma
About this trial
This is an interventional treatment trial for Acute Pain Due to Trauma focused on measuring Methoxyflurane, emergency, trauma pain, inhaled analgesia
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
Sites / Locations
- Hospital de Viladecans
- Hospital del Bierzo
- Hospital Asepeyo Coslada
- Hospital Puerta de Hierro
- Hospital Álvaro Cunqueiro
- Hospital Gernika-Lumo
- Hospital General de Alicante
- Hospital Universitario La Princesa
- Hospital Clínico San Carlos
- SUMMA - Comunidad de Madrid
- Hospital La Paz
- Hospital Virgen del Rocío
- Hospital Campo Grande
- Complejo Asistencial de Zamora
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Methoxyflurane
Standard of Care (SoC)
Patients will be supplied with up to two inhalers containing 3 mL methoxyflurane. A member of the research team will train the patient to self-administer methoxyflurane
Patients will be treated following standard of care (SoC) of the hospital, for emergency relief of trauma and associated pain. Any kind of analgesia administered by any route will be valid. Only administration of one analgesic (or fixed combinations) at baseline will considered SoC. Other required analgesics will be considered rescue medication.