Methoxyflurane efficacy and safety in hostile environment

Phase 1

• Conditions: moderate to severe pain secondary to minor trauma; MedDRA version: 21.1Level: PTClassification code 10072132Term: Fracture painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-004601-40-IT
• Lead Sponsor: MUNDIPHARMA RESEARCH LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Age = 18 years.
••Stable, vigilant and collaborating patient able to understand and communicate with the investigator to perform the study activities.
• Minor trauma to the limbs (fracture, dislocation, dislocation, crushing, contusion) in a single district. N.B. for the recruitment, given the particular setting, instrumental confirmation is not required but the suspicion of involvement of a single district is sufficient.
• Patient with moderate to severe pain secondary to minor trauma, measured by Numerical Rating Scale (NRS scores =4).
• Written informed consent must be given by each patient before any study-specific activity. In cases where the patient is not able to write autonomously, verbal consent must be obtained in the presence of an impartial witness who, as soon as he is able, will be required to confirm independently

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Hypersensitivity to methoxyflurane, to any fluorinated anesthetic or to the excipient Butylhydroxytoluene E321.
•Personal or family history (parents or siblings) for malignant hyperthermia.
•A history of serious adverse reactions to inhaled anesthetics.
•A history of renal failure.
•Positive history of liver failure.
•Clinically evident cardiovascular instability.
•Clinically evident respiratory depression.
•Lactation and known or suspected pregnancy condition as reported by the patient. N.B. a delay of only one day is also considered suspect of pregnancy with respect to the scheduled date of menstruation (28 days from the beginning of the last one).
•Treatment in progress with any analgesic for chronic pain or in the previous 8 hours.
•Acute intoxication by drugs, drugs or alcohol.
•Imminent risk of life requiring hospitalization or resuscitation.
•Altered vigilance and / or conscience level [Glasgow Coma Scale (GCS) <15]

Study & Design

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