Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

A Phase IV, Randomized, Double Blind, Single Centre, Placebo Controlled Study to Assess the Safety and Efficacy of Methoxyflurane [Penthrox] for the Treatment of Incident Pain in Participants Undergoing a Bone Marrow Biopsy Procedure

This study aims to provide further supportive evidence that Methoxyflurane, a potent analgesic, administered using the Penthrox Inhaler is safe and efficacious in adult participants, specifically those who experience incident pain associated with a planned bone marrow biopsy.

Inclusion Criteria:

• Adult participants (18 years of age or older)
• Able to give written informed consent
• Anticipated episode(s) of incident pain related to planned BMB lasting no more than 30 minutes on average
• Anticipated life expectancy of at least 1 month

Pre-Exclusion Criteria:

• Subjects with a clinical condition that may, in the opinion of the investigator, impact on the subject's ability to participate in the study, or on the study results
• Participants who have had IV sedation/opioid on previous BMB and who wish to receive IV sedation/opioid on this occasion or who in the opinion of the BMB operator would be advised to receive IV sedation/opioid on this occasion
• Concomitant use of other investigational agents
• Concomitant use of nephrotoxic agents such as gentamicin
• Uncontrolled INR (>4)
• Personal or familial hypersensitivity to fluorinated anaesthetics
• Personal or familial malignant hyperthermia
• Respiratory rate of less than 10 per minute
• Has previously received methoxyflurane
• Known pre-existing renal or hepatic impairment
• Compromised Renal Function (creatinine ≥ 1.5 x ULNR)
• Compromised Liver Function (bilirubin ≥ 2.5 x ULNR)

Exclusion Criteria:

• Premedication with anxiolytic (e.g. midazolam, diazepam)
• Dosed with breakthrough dose of analgesic that may contribute to control of pain during the planned procedure