Trial | NCT00524927  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    110
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.
Study Started
Sep 30
2007
Study Completion
Nov 30
2009
Last Update
Jan 28
2010
Estimate

Drug Methoxyflurane

Drug Normal Saline

A Active Comparator

B Placebo Comparator

Criteria 

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
No Results Posted