Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

Pain Measurement Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524927
• Other study ID #: 06/61
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2007
• Last updated: January 27, 2010
• Start date: September 2007
• Est. completion date: November 2009

Study information

• Verified date: January 2010
• Source: Medical Developments International Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Measurement

Intervention

Drug:
• Methoxyflurane

• Normal Saline

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Medical Developments International Limited	Australian Department of Industry, Tourism and Resources

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy
Secondary	Determine the safety of Methoxyflurane