Status:
COMPLETED
Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units
Lead Sponsor:
Mundipharma Pharmaceuticals S.L.
Collaborating Sponsors:
Spanish Society for Emergency Medicine (SEMES)
Spanish Clinical Research Network - SCReN
Conditions:
Acute Pain Due to Trauma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 unit...
Detailed Description
Open, randomized clinical trial to compare emergency pain relief between methoxyflurane and standard of care in patients with trauma and associated pain, treated in Spanish emergency units. Methoxyfl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT03256903
Start Date
July 7 2017
End Date
July 31 2018
Last Update
August 20 2018
Active Locations (14)
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1
Hospital de Viladecans
Viladecans, Barcelona, Spain, 08840
2
Hospital del Bierzo
Ponferrada, León, Spain, 24404
3
Hospital Asepeyo Coslada
Coslada, Madrid, Spain, 28823
4
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222