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Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524927
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : January 28, 2010
Australian Department of Industry, Tourism and Resources
Information provided by:
Medical Developments International Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Measurement Drug: Methoxyflurane Drug: Normal Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2007
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: A Drug: Methoxyflurane
Placebo Comparator: B Drug: Normal Saline

Primary Outcome Measures :
  1. Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy

Secondary Outcome Measures :
  1. Determine the safety of Methoxyflurane

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00524927

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Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Medical Developments International Limited
Australian Department of Industry, Tourism and Resources
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Principal Investigator: Odette Spruyt, MD Peter MacCallum Cancer Centre, Australia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Greg Plunkett, Regulatory Affairs Manager, Medical Developments International Identifier: NCT00524927    
Other Study ID Numbers: 06/61
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010
Keywords provided by Medical Developments International Limited:
Incident Pain
Bone Marrow Biopsy
Additional relevant MeSH terms:
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Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs