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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00524927
Other study ID # 06/61
Secondary ID
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
Est. primary completion date
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


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
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