Trauma acute pain treatment with methoxyflurane vaporized (PENTHROX®): efficacy and safety study.

Phase 1

• Conditions: Acute trauma pain; MedDRA version: 20.0Level: PTClassification code 10072132Term: Fracture painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2017-001565-25-IT
• Lead Sponsor: MUNDIPHARMA PHARMACEUTICALS SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-02
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• 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)
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

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 FR> 20 and SatO2 in air <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 IMAO (ongoing or interrupted less 3 wks ago)
•Theatment with naltrexone
•History of active or recurrent peptic ulcer/hemorrhage (2 or more episodes of documented ulceration or bleeing 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified