Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma

• Status: Completed
• Trial end date: 2018-12-20
• Target enrollment: 0
• Participant gender: All

Summary

A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated with a trauma

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma SAS
• Collaborators: AXONAL; Exystat
• Treatments: Methoxyflurane

Criteria

Inclusion Criteria:

• Men and women aged 18 or older

• Patients (in an emergency, parent or relative) who dated and signed their informed consent to participate in the study

• Patients admitted to the emergency department due to a trauma

• Patients having a pain score ≥ 4 measured using a numerical scale (NRS) at the time of admission to emergency departments.

• Patients having a pain score ≥ 40 measured using the VAS at the time of randomisation.

Exclusion Criteria:

• Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit;

• Impaired consciousness according to the investigator regardless of the cause, including head trauma or drug or alcohol consumption;

• Acute medicinal or alcohol intoxication, according to the investigator;

• Pregnant woman or woman at risk of pregnancy and not using highly effective contraception methods or known lactation;

• Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission, except for paracetamol, which is allowed;

• Treatment with nitrous oxide within 5 hours before presentation at the emergency department;

• Use of analgesics for chronic pain;

• Prior use of Penthrox®;

• Use of an investigational product one month before presentation at the emergency department;

• Hypersensitivity to Penthrox® or any other fluoridated anesthetic;

• History of signs of hepatic lesions after use of methoxyflurane or after anaesthesia by a halogenated hydrocarbon;

• Malignant hyperthermia: Known malignant hyperthermia or patient genetic predisposition or patient or family history of serious adverse reactions;

• Clinical evidence of respiratory depression according to the investigator;

• Clinical evidence of cardiovascular instability according to the investigator;

• Clinical renal or hepatic damage, according to the investigator, pre-existing or known;

• Presence of any other clinical condition that can, according to the investigator's opinion, have an impact on the patient's ability to participate in the study or the results of the study.

• Individuals protected by law