Acute Pain Due to Trauma
Conditions
Keywords
Methoxyflurane, emergency, trauma pain, inhaled analgesia
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.
Interventions
DRUGMethoxyflurane
Up to two inhalers containing 3 mL methoxyflurane. Treatment duration: 1 administration in 1 day.
DRUGStandard of care
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
Sponsors
Mundipharma Pharmaceuticals S.L.
Spanish Society for Emergency Medicine (SEMES)
Spanish Clinical Research Network - SCReN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase IIIb open randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Responders | from baseline to 20 minutes post dose | Pain Responders (with \>30% pain relief compared to baseline) at 20 min |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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) |
Countries
Spain
Outcome results
None listed