ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

PROMPT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Interventional Radiology procedural analgesia

Condition category

Condition code

Anaesthesiology

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]

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]

The efficacy and safety of methoxyflurane use in interventional radiology procedures using using Clavien Dindo classification.

Timepoint [1]

Before patient is discharged from the department (upto ~3hours after the procedure).

Primary outcome [2]

Pain levels assessed using visual-analogue scale (VAS)

Timepoint [2]

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]

Anxiety assessed using Generalized Anxiety Disorder 2 (GAD-2).

Timepoint [3]

Secondary outcome [1]

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]

Before patient is discharged from the department; This will be done in roughly 30-60mins after the procedure.

Secondary outcome [2]

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]

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?

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)

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Ross Copping

Address [1]

75 Elizabeth St, Liverpool NSW 2170

Country [1]

Australia

Funding source category [2]

Self funded/Unfunded

Name [2]

Paul Balamon

Address [2]

75 Elizabeth St, Liverpool NSW 2170

Country [2]

Australia

Funding source category [3]

Self funded/Unfunded

Name [3]

Jules Catt

Address [3]

75 Elizabeth St, Liverpool NSW 2170

Country [3]

Australia

Funding source category [4]

Hospital

Name [4]

Liverpool Hospital (Interventional Radiology Deparment).

Address [4]

Interventional Radiology Deparment, Liverpool Hospital , Elizabeth Drive, Goulburn St, Liverpool NSW 2170

Country [4]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Liverpool HospitalCorner of Elizabeth and Goulburn Streets LIVERPOOL NSW 2170

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/04/2021

Approval date [1]

26/06/2021

Ethics approval number [1]

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

Dr Ross Copping

Address

Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170

Country

Australia

Phone

+6128738 7056

Fax

+61287387062

[email protected]

Contact person for public queries

Name

Ross Copping

Address

Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170

Country

Australia

Phone

+6128738 7056

Fax

+61287387062

[email protected]

Contact person for scientific queries

Name

Ross Copping

Address

Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170

Country

Australia

Phone

+6128738 7056

Fax

+61287387062

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13491	Study protocol			[email protected]		382917-(Uploaded-09-10-2021-20-12-56)-Study-related document.pdf
13492	Informed consent form			[email protected]		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.

Trial Review

Documents added manually

Documents added automatically