Trauma Acute Pain Treatment With Methoxyflurane Vaporized (PENTHROX®): Efficacy and Safety Study (MEDITA)

Exclusion Criteria

• •Personal or family history (parents or siblings) for malignant hyperthermia.
• •History of severe adverse reactions to inhaled anesthetics.
• •History of renal failure
• •History of liver failure.
• •Trauma risky dynamics (ejection from the vehicle, cabin deformation, death of an occupant of the same vehicle, motor vehicle / pedestrian or cyclist impact with a motor vehicle in motion, projection / overturn, fall from a height of\> 3 meters, extraction on event place \> 20 min).
• •Altered level of vigilance and / or conscience (GCS \<15)
• •Symptomatic hypotension or Systolic Pressure \<100 mm / Hg
• •Discomfort with Respiratory Rate \> 20 and Oxygen Saturation \<95%
• •Known pregnancy status.Note: a 1 day delay with respect to the planned menstruation date (28days since the beginning of the previous one) has to be considered a suspected pregnancy.
• •Hypersensitivity to methoxyflurane, to any fluorinated anesthetic or to the E321 butylhydroxytoluene excipient.
• •Current treatment with any analgesic for chronic pain or in the previous 5 hours (8 hours in the case of diclofenac).
• •Known allergy to both paracetamol and non-steroidal anti-inflammatory drugs or known hypersensitivity to morphine
• •All types of acute abdomen and paralytic ileus
• •Hearth failure
• •Recent (within2 months) biliary tract surgery
• •Current bronchial asthma attack
• •Uncontrolled epilepsy
• •Depressive state treated with Monoamine Oxidase Inhibitors (ongoing or interrupted less 3 wks ago)
• •Treatment with naltrexone
• •History of active or recurrent peptic ulcer/hemorrhage (2 or more episodes of documented ulceration or bleeding in the last 6 months)
• •Bleeding diathesis
• •Current Intensive diuretic therapy
• •Chronic dyspepsia, gastritis with significant episodes in the last 2 months
• •Leucopenia and thrombocytopenia, current hemorrhages
• •Current anticoagulant therapy