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
  Purpose

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 Intervention Phase
Pain Measurement
Drug: Methoxyflurane
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Medical Developments International Limited:

Primary Outcome Measures:
  • 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:
  • Determine the safety of Methoxyflurane

Estimated Enrollment: 110
Study Start Date: September 2007
Study Completion Date: November 2009
Arms Assigned Interventions
Active Comparator: A Drug: Methoxyflurane
Placebo Comparator: B Drug: Normal Saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524927

Locations
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Medical Developments International Limited
Australian Department of Industry, Tourism and Resources
Investigators
Principal Investigator: Odette Spruyt, MD Peter MacCallum Cancer Centre, Australia
  More Information

No publications provided

Responsible Party: Greg Plunkett, Regulatory Affairs Manager, Medical Developments International
ClinicalTrials.gov Identifier: NCT00524927     History of Changes
Other Study ID Numbers: 06/61
Study First Received: September 2, 2007
Last Updated: January 27, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Medical Developments International Limited:
Incident Pain
Bone Marrow Biopsy

Additional relevant MeSH terms:
Methoxyflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014