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OpenTrials
Completed

NCT Number: NCT00524927

Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

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.

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Key information

Conditions

Pain Measurement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3002, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methoxyflurane

Drug

normal saline

Drug

Primary outcomes

  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 outcomes

  1. Determine the safety of Methoxyflurane

Sponsors and collaborators

Lead sponsor

Medical Developments International Limited

Industry

Collaborators

  • Australian Department of Industry, Tourism and Resources

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2009
First posted
Sep 5, 2007
Registry last updated
Jan 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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