Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Pharmaceuticals S.L.
• Collaborators: Spanish Clinical Research Network - SCReN; Spanish Clinical Research Network (SCReN); Spanish Society for Emergency Medicine (SEMES)
• Treatments: Analgesics; Methoxyflurane

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