Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

This study has been completed.
Sponsor:
Collaborator:
Australian Department of Industry, Tourism and Resources
Information provided by:
Medical Developments International Limited
ClinicalTrials.gov Identifier:
NCT00524927
First received: September 2, 2007
Last updated: January 27, 2010
Last verified: January 2010

September 2, 2007
January 27, 2010
September 2007
Not Provided
Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy
Same as current
Complete list of historical versions of study NCT00524927 on ClinicalTrials.gov Archive Site
Determine the safety of Methoxyflurane
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain Measurement
  • Drug: Methoxyflurane
  • Drug: Normal Saline
  • Active Comparator: A
    Intervention: Drug: Methoxyflurane
  • Placebo Comparator: B
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
November 2009
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00524927
06/61
Yes
Greg Plunkett, Regulatory Affairs Manager, Medical Developments International
Medical Developments International Limited
Australian Department of Industry, Tourism and Resources
Principal Investigator: Odette Spruyt, MD Peter MacCallum Cancer Centre, Australia
Medical Developments International Limited
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP