Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mundipharma Pharmaceuticals srl
With
Bioikos Ambiente Srl
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent must be provided by each patient prior to any study-specific activity. In cases where the patient is unable to write autonomously, it must be obtained a verbal consent in presence of a witness that the patient will have to confirm autonomously as soon as (s)he is able
Stable, vigilant and collaborative patient i.e. able to understand and communicate with the examiner in order to carry out the study activities
Age ≥ 18 years
Trauma to the limbs (fracture, dislocation, crushing, bruising) in a single district.
N.B. For recruiting, given the particular setting, no instrumental confirmation is required but suspicion of involvement of a single district is sufficient.
\- Moderate to severe pain, detected by the Numerical Rating Scale (NRS score ≥4)
You may not be if
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
Clareo Health | Trauma Acute Pain Treatment With Methoxyflurane Vaporized (PENTHROX®): Efficacy and Safety Study (MEDITA)
