Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001127695
Ethics application status
Approved
Date submitted
23/09/2023
Date registered
1/11/2023
Date last updated
1/11/2023
Date data sharing statement initially provided
1/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
PROMPT: PROcedural sedation vs Methoxyflurane a Prospective cohorT Study.
Scientific title
Prospective randomised double arm study comparing safety, pain and anxiety outcomes between methoxyflurane vs intravenous fentanyl and midazolam for patients requiring interventional radiological procedures
Secondary ID [1] 305504 0
Nil
Universal Trial Number (UTN)
Trial acronym
PROMPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interventional Radiology procedural analgesia 323894 0
Condition category
Condition code
Anaesthesiology 321409 321409 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective randomised double arm study comparing methoxyflurane vs intravenous fentanyl and midazolam for patients requiring periprocedural analgesia or sedation.

Penthrox® (1 ampule of 3ml methoxyflurane administered via the “green whistle”) plus local anaesthetic. Patients 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] 321906 0
Treatment: Drugs
Comparator / control treatment
Patients will receive intravenous fentanyl and midazolam in titrated aliquots (fentanyl is generally given in incriments of 100mcg intravenous, and midazolam in incriments of 1mg) by the direction of the proceduralist and administered by sedation nurses.
.
Control group
Active

Outcomes
Primary outcome [1] 329183 0
The efficacy and safety of methoxyflurane use in interventional radiology procedures using using Clavien Dindo classification.
Timepoint [1] 329183 0
Before patient is discharged from the department (upto ~3hours after the procedure).
Primary outcome [2] 336249 0
Pain levels assessed using visual-analogue scale (VAS)
Timepoint [2] 336249 0
Baseline score before procedure (~30min)
at set intervals during the procedure (every 10mins for the duration of the procedure)
Before patient is discharged from the department (~1hour after the procedure).
Primary outcome [3] 336250 0
Anxiety assessed using Generalized Anxiety Disorder 2 (GAD-2).
Timepoint [3] 336250 0
Baseline score before procedure (~30min)
at set intervals during the procedure (every 10mins for the duration of the procedure)
Before patient is discharged from the department (~1hour after the procedure).
Secondary outcome [1] 401726 0
A study-specific survey has post procedure questionnaires will include assessment of patient experience, willingness to undergo the procedure again with this form of analgesia or sedation, and satisfaction with care.
Timepoint [1] 401726 0
Before patient is discharged from the department; This will be done in roughly 30-60mins after the procedure.
Secondary outcome [2] 427528 0
Procedure duration is recored using medical recores as per the standard of care for all procedures performed; this will be used to complete data collection.
Timepoint [2] 427528 0
This will be calculated based on the duration of the proccedure at the end of the proccedure.

Eligibility
Key inclusion criteria
Patients requiring periprocedural analgesia or sedation above local anaesthesia alone for procedures in the Liverpool Hospital Interventional Radiology Department will be offered participation in the study. Participants 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. Expected procedure time must be under 2 hours.

able to consent for procedure and participation in research
patients requiring periprocedural analgesia or sedation above local anaesthesia alone
hemodynamically stable
expected procedure time <2h
over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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. Similarly, if a sufficient understanding or communication cannot be established, including NESB/CALD, the patient will need to be excluded from the study and included in the discussion/exclusions analysis.

Any patient with allergy or prior adverse reaction to methoxyflurane, midazolam or fentanyl will be excluded from the study. Patients requiring general anaesthesia or formal support by anaesthetist (e.g. needing intubation) will also be excluded.


Patients with impaired renal function (eGFR<50) or liver dysfunction will be excluded due to the random possibility of receiving methoxyflurane as per standard of care for the safe administration of methoxyflurane 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
requiring general anaesthesia or formal support by anaesthetist (e.g. needing intubation)
prior allergy or adverse reaction to methoxyflurane, midazolam or fentanyl

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 patient-lead sedation (inhaled methoxyflurane via “the green whistle”) or doctor/nurse lead sedation (IV fentanyl and midazolam). 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be predetermined and generated by a randomisation engine (randomizer.org) in order to allocate participants into two groups, either patient-lead sedation (inhaled methoxyflurane via “the green whistle”) or doctor/nurse lead sedation (IV fentanyl and midazolam).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Prospective randomised double arm study comparing methoxyflurane vs intravenous fentanyl and midazolam.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/08/2021
Date of last participant enrolment
Anticipated
23/09/2024
Actual
Date of last data collection
Anticipated
23/09/2024
Actual
Sample size
Target
150
Accrual to date
82
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20708 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 35510 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 309863 0
Self funded/Unfunded
Name [1] 309863 0
Ross Copping
Country [1] 309863 0
Australia
Funding source category [2] 314963 0
Self funded/Unfunded
Name [2] 314963 0
Paul Balamon
Country [2] 314963 0
Australia
Funding source category [3] 314964 0
Self funded/Unfunded
Name [3] 314964 0
Jules Catt
Country [3] 314964 0
Australia
Funding source category [4] 315062 0
Hospital
Name [4] 315062 0
Liverpool Hospital (Interventional Radiology Deparment).
Country [4] 315062 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] 310901 0
None
Name [1] 310901 0
Address [1] 310901 0
Country [1] 310901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309601 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309601 0
Liverpool HospitalCorner of Elizabeth and Goulburn Streets LIVERPOOL NSW 2170
Ethics committee country [1] 309601 0
Australia
Date submitted for ethics approval [1] 309601 0
21/04/2021
Approval date [1] 309601 0
26/06/2021
Ethics approval number [1] 309601 0
2021/ETH00822

Summary
Brief summary
Procedures performed in interventional radiology are often quick and minimally invasive, however some procedures traditionally require increased pain relief and sedation than local anaesthetic alone. For these procedures, we have previously used intravenous medications (midazolam and fentanyl) for sedation and pain relief; however, dosing of these medications is controlled by your nurse or doctor which can lead to under or over dosing of medications, or delayed pain relief due to delays in administration of medication. We believe that letting the patient control how much medication and how often can be effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114726 0
Dr Ross Copping
Address 114726 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 114726 0
Australia
Phone 114726 0
+6128738 7056
Fax 114726 0
+61287387062
Email 114726 0
ross.copping@health.nsw.gov.au
Contact person for public queries
Name 114727 0
Dr Ross Copping
Address 114727 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 114727 0
Australia
Phone 114727 0
+6128738 7056
Fax 114727 0
+61287387062
Email 114727 0
ross.copping@health.nsw.gov.au
Contact person for scientific queries
Name 114728 0
Dr Ross Copping
Address 114728 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 114728 0
Australia
Phone 114728 0
+6128738 7056
Fax 114728 0
+61287387062
Email 114728 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
13491Study protocol  paulbalamon@gmail.com 382917-(Uploaded-09-10-2021-20-12-56)-Study-related document.pdf
13492Informed consent form  paulbalamon@gmail.com 382917-(Uploaded-09-10-2021-20-13-09)-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.