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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
History of Changes
  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
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 May 19, 2013