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

Mundipharma Pharmaceuticals S.L.310 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

310

Conditions

Acute Pain Due to Trauma

Interventions

MethoxyfluraneDRUG

Up to two inhalers containing 3 mL methoxyflurane. Treatment duration: 1 administration in 1 day.

Standard of careDRUG

Any kind of analgesia, administered by any route for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Hospital de Viladecans

Viladecans, Barcelona, Spain

Hospital del Bierzo

Ponferrada, León, Spain

Hospital Asepeyo Coslada

Coslada, Madrid, Spain

Outcomes

Primary Outcomes

Pain relief

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)

Time frame: At baseline, 3, 5, 10, 15 and 20 minutes from STA

Analgesia effectiveness

Difference between arms related to analgesia effectiveness

Time frame: Change from baseline to 3, 5, 10, 15, 20 and 30 min

Analgesia speed of action

Difference between arms related to speed of action of analgesia for all patients

Time frame: From time of randomization up to 20 minutes

Safety for patients with severe pain, treated with second or third step analgesics

Difference between arms related to safety for patients with severe pain (NRS \>7), treated with second or third step analgesics

Time frame: Up until 14 days from STA

Patient-averaged summed pain intensity difference 15 min after STA

Time frame: from baseline to 3, 5, 10 and 15 minutes post dose

Pain Responders

Pain Responders (with \>30% pain relief compared to baseline) at 20 min

Time frame: from baseline to 20 minutes post dose

Secondary Outcomes

Investigators and patients satisfaction

Investigators and patients satisfaction measured as convenience, treatment efficacy and adverse events, using NRS scales (0-10)

Time frame: 30 min from start of administration

Data from ClinicalTrials.gov

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