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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain
Scientific 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
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain Measurement 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Methoxyflurane
Treatment: Drugs - Normal Saline

Active Comparator: A -

Placebo Comparator: B -

Treatment: Drugs: Methoxyflurane

Treatment: Drugs: Normal Saline

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Determine the safety of Methoxyflurane
Timepoint [1] 0 0

Key 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

Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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)

- 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Medical Developments International Limited
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Australian Department of Industry, Tourism and Resources
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief 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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Odette Spruyt, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications