Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units
- Conditions
- Acute Pain Due to Trauma
- Interventions
- Drug: Standard of care
- Registration Number
- NCT03256903
- Lead Sponsor
- Mundipharma Pharmaceuticals S.L.
- 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 units.
- 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.
Methoxyflurane is a fluorinated ethyl methyl ether, with the chemical name 2:2-dichloro-1:1-difluoroethyl methyl ether. It belongs to the fluorinated hydrocarbon group of volatile anaesthetics. It is inhaled as a vapour at low (sub-anaesthetic) concentrations to achieve an analgesic effect for the management of pain.
In Europe countries, where methoxyflurane is already marketed, it is indicated for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.
On the other hand, current clinical practice includes a variety of analgesic agents, with the choice of which to employ based on consideration of the risk-benefit factors of each class of drug, as well as the type of pain, its severity, and the risk of adverse effects.
The main objective of this study is to assess Methoxyflurane's significant advantage in terms of anaglesic effectiveness, as it is known as a rapidly acting, non-narcotic analgesic for the treatment of emergency pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (SoC) Standard of care 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. Methoxyflurane Methoxyflurane 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
- Primary Outcome Measures
Name Time Method Patient-averaged summed pain intensity difference 15 min after STA from baseline to 3, 5, 10 and 15 minutes post dose Patient-averaged summed pain intensity difference 15 min after STA
Pain relief At baseline, 3, 5, 10, 15 and 20 minutes from STA Change in mean pain intensity over 20 min from start of administration (STA) and time to first pain relief, measured by numeric scale (0-10)
Analgesia effectiveness Change from baseline to 3, 5, 10, 15, 20 and 30 min Difference between arms related to analgesia effectiveness
Analgesia speed of action From time of randomization up to 20 minutes Difference between arms related to speed of action of analgesia for all patients
Pain Responders from baseline to 20 minutes post dose Pain Responders (with \>30% pain relief compared to baseline) at 20 min
Safety for patients with severe pain, treated with second or third step analgesics Up until 14 days from STA Difference between arms related to safety for patients with severe pain (NRS \>7), treated with second or third step analgesics
- Secondary Outcome Measures
Name Time Method Patient and investigators' fulfillment of expectations 30 min from start of administration Patient and investigators' fulfillment of expectations, measured with a 5 items Likert scale
Patients' Global Impression of Change with the treatments Up until 30 minutes from STA Patients' Global Impression of Change with the treatments, measured using a 7 items Likert scale
Investigators and patients satisfaction 30 min from start of administration Investigators and patients satisfaction measured as convenience, treatment efficacy and adverse events, using NRS scales (0-10)
Treatment cost of pain relief Up until 60 minutes from randomization Treatment cost of pain relief, measured considering use of fungible material; need of nurse to administer iv treatments; time to discharge
Safety rates of treatment emergent adverse events Up until 14 days from STA Safety rates of treatment emergent adverse events (TEAE) in both arms, including alterations in biochemical and blood count.
Trial Locations
- Locations (14)
Hospital del Bierzo
🇪🇸Ponferrada, León, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Complejo Asistencial de Zamora
🇪🇸Zamora, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Gernika-Lumo
🇪🇸Gernika-Lumo, Vizcaya, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Campo Grande
🇪🇸Valladolid, Spain
Hospital de Viladecans
🇪🇸Viladecans, Barcelona, Spain
Hospital Asepeyo Coslada
🇪🇸Coslada, Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
SUMMA - Comunidad de Madrid
🇪🇸Madrid, Spain