Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00524927




Registration number
NCT00524927
Ethics application status
Date submitted
2/09/2007
Date registered
5/09/2007
Date last updated
28/01/2010

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
06/61
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: A -

Placebo comparator: B -

Comparator / control treatment
Control group

Outcomes
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

Eligibility
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

Pre-
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Treatment
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
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
Name
Medical Developments International Limited
Address
Country
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

Summary
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
https://clinicaltrials.gov/study/NCT00524927
Trial related presentations / publications
Spruyt O, Westerman D, Milner A, Bressel M, Wein S. A randomised, double-blind, placebo-controlled study to assess the safety and efficacy of methoxyflurane for procedural pain of a bone marrow biopsy. BMJ Support Palliat Care. 2014 Dec;4(4):342-8. doi: 10.1136/bmjspcare-2013-000447. Epub 2013 Jun 7.
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00524927