Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001167651
Ethics application status
Approved
Date submitted
23/09/2023
Date registered
10/11/2023
Date last updated
10/11/2023
Date data sharing statement initially provided
10/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
MONITOR - MethOxyfluraNe in InTerventiOnal Radiology
Scientific title
Prospective double blind randomised controlled study comparing patient experience and analgesia, between methoxyflurane (Penthrox®) vs placebo for patients requiring interventional radiological procedures
Secondary ID [1] 305502 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MONITOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep tissue core biopsy 323893 0
Insertion or removal of portacaths. 331674 0
Condition category
Condition code
Anaesthesiology 321408 321408 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MONITOR trial is a prospective double-blind randomised control study comparing the efficacy of methoxyflurane (Penthrox®) vs placebo for interventional radiology procedures.

If patients meet the inclusion criteria they will be randomised to receive placebo and local anaesthetic or Penthrox® (1 ampule of 3ml methoxyflurane administered via the “green whistle”) plus local anaesthetic.

Patients in both arms of the trial will be educated on safe use of the “green whistle” and be able to use it for the duration of the procedure.
Intervention code [1] 321905 0
Treatment: Drugs
Comparator / control treatment
The MONITOR trial is a prospective double-blind randomised control study comparing the efficacy of methoxyflurane (Penthrox®) vs placebo for interventional radiology procedures.

If patients meet the inclusion criteria they will be randomised to receive placebo and local anaesthetic or Penthrox® (1 ampule of 3ml methoxyflurane administered via the “green whistle”) plus local anaesthetic.

The Penthrox® green whistle vs placebo will be indistinguishable; The most characteristic feature of the medication to the patient is the smell, so a few drops of methoxyflurane will be added to the wristband of the empty placebo “green whistle” in order to mimic this and create a more robust placebo.

This is well below the amount required for any therapeutic effect and a technique used in other blinded published studies of methoxyflurane.

Patients in both arms of the trial will be educated on safe use of the “green whistle” and be able to use it for the duration of the procedure.
Control group
Placebo

Outcomes
Primary outcome [1] 329182 0
The efficacy and safety of methoxyflurane use in interventional radiology procedures using using Clavien Dindo classification.
Timepoint [1] 329182 0
Before patient is discharged from the department (upto ~3hours after the procedure).
Primary outcome [2] 336245 0
Pain levels assessed using visual-analogue scale (VAS)
Timepoint [2] 336245 0
Baseline score before procedure (~30min)
at set intervals during the procedure (every 5mins for the duration of the procedure)
Before patient is discharged from the department (~1hour after the procedure).
Primary outcome [3] 336246 0
Anxiety assessed using Generalized Anxiety Disorder 2 (GAD-2)
Timepoint [3] 336246 0
Baseline score before procedure (~30min)
at set intervals during the procedure (every 5mins for the duration of the procedure)
Before patient is discharged from the department (~1hour after the procedure).
Secondary outcome [1] 401725 0
A study-specific survey has post procedure questionnaires will include assessment of patient experience, and satisfaction with care.
Timepoint [1] 401725 0
Before patient is discharged from the department; This will be done in roughly 30-60mins after the procedure.
Secondary outcome [2] 427522 0
A study-specific survey of proceduralist satisfaction with analgesia performed post procedure questionnaires.
Timepoint [2] 427522 0
Before patient is discharged from the department
Secondary outcome [3] 427523 0
Procedure duration
Timepoint [3] 427523 0
Procedure duration is recorded using medical recoreds at the conclusion of the procedure.

Eligibility
Key inclusion criteria
All patients undergoing deep tissue biopsy and insertion or removal of portacaths in the Liverpool Hospital Interventional Radiology Department will be offered participation in the study. Methoxyflurane is routinely used as an adjunct to local anaesthesia for these procedures in our department. Patients must be over 18 years of age and have capacity to provide consent. Written informed voluntary consent will be obtained. Patients must be hemodynamically stable and afebrile.


deep tissue biopsies
portacath insertions
portacath removal
able to consent
hemodynamically stable
afebrile
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Low acuity outpatient procedures have deliberately been selected for the purposes of this study. These typically require low levels of sedation. Patients who require definite IV sedation, who are pregnant or in whom it is not appropriate to blind to no sedation will be excluded from the study.

The research project will be discussed with the patients at the time of consent. It will be clearly explained that they may opt out of the study or deny/withdraw consent at any stage. Patients unable to provide informed, voluntary, competent consent will be excluded. Any patient with allergy or prior adverse reaction to methoxyflurane will not be given methoxyflurane and therefore excluded from the study.


Patients with impaired renal function (eGFR<50) or liver dysfunction will be excluded as per standard of care for the safe administration of Penthrox® based on the Australia Medical Handbook, Liverpool Hospital protocol and the Australian Therapeutic Goods Administration.
renal impairment (eGFR<50)
liver dysfunction
pregnancy
opt out or refusal
definite IV sedation required
clinically inappropriate to blind to possibility of no additional analgesic adjunct

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)
Randomisation will be predetermined and generated by a randomisation engine (randomizer.org) in order to allocate participants into two groups, either Penthrox® (inhaled methoxyflurane via “the green whistle”) or placebo (empty training “green whistle”). The results will be stored securely in sealed envelopes in the interventional radiology department, consecutively numbered and only accessible to the clinical nurse educator/study nurse. Once a patient is assessed and enrolled at the time of consent, the envelope will be opened revealing the allocated study group only to the study nurse. The proceduralist, assistants, scrub and scout nurses, sedation nurse and patient will be blinded to the process and the study group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Prospective double blind randomised controlled study comparing methoxyflurane (Penthrox®) vs placebo.
- Prospective double-blind randomised control study.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed by the investigators using Microsoft Excel and SPSS. Continuous variables will be summarised using mean (standard deviation) or median (interquartile range) where appropriate and comparison between the study groups will be made using the student T test or the Mann-Whitney U test. Categorical variables will be recorded as counts and percentages and comparisons between the study groups will be made using chi-square or Fisher’s exact test. Calculated P-values will be two tailed with P<0.05 indicating statistical significance. Non-inferiority analysis will also be implemented with significance level (alpha) 5%, power 90%, percentage success expected in each group >90% and non inferiority limit (d) 20%.

Statistical analysis will be conducted in conjunction with the biostatistician for power and data analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/10/2022
Date of last participant enrolment
Anticipated
25/09/2024
Actual
Date of last data collection
Anticipated
25/09/2024
Actual
Sample size
Target
400
Accrual to date
321
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20707 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 35509 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 309862 0
Self funded/Unfunded
Name [1] 309862 0
Ross Copping
Country [1] 309862 0
Australia
Funding source category [2] 314960 0
Self funded/Unfunded
Name [2] 314960 0
Paul Balamon
Country [2] 314960 0
Australia
Funding source category [3] 314961 0
Hospital
Name [3] 314961 0
Interventional Radiology Deparment, Liverpool Hospital
Country [3] 314961 0
Australia
Funding source category [4] 315065 0
Commercial sector/Industry
Name [4] 315065 0
Medical Developments International (MDI)
Country [4] 315065 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District Human Research Ethics Committee
Address
Liverpool Hospital , Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 316961 0
None
Name [1] 316961 0
Address [1] 316961 0
Country [1] 316961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309600 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309600 0
Ethics committee country [1] 309600 0
Australia
Date submitted for ethics approval [1] 309600 0
04/05/2021
Approval date [1] 309600 0
27/06/2021
Ethics approval number [1] 309600 0
2021/ETH00524

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114722 0
Dr Ross Copping
Address 114722 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 114722 0
Australia
Phone 114722 0
+6128738 7056
Fax 114722 0
+61287387062
Email 114722 0
ross.copping@health.nsw.gov.au
Contact person for public queries
Name 114723 0
Ross Copping
Address 114723 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 114723 0
Australia
Phone 114723 0
+6128738 7056
Fax 114723 0
+61287387062
Email 114723 0
ross.copping@health.nsw.gov.au
Contact person for scientific queries
Name 114724 0
Ross Copping
Address 114724 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 114724 0
Australia
Phone 114724 0
+6128738 7056
Fax 114724 0
+61287387062
Email 114724 0
ross.copping@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13489Study protocol  paulbalamon@gmail.com 382916-(Uploaded-04-10-2023-19-21-22)-Study-related document.pdf
13490Informed consent form  paulbalamon@gmail.com 382916-(Uploaded-04-10-2023-19-23-29)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.