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Trial registered on ANZCTR


Registration number
ACTRN12614000853640
Ethics application status
Approved
Date submitted
31/07/2014
Date registered
8/08/2014
Date last updated
8/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Methoxyflurane analgesia during local anaesthetics injections.
Scientific title
Evaluation of the safety of use of methoxyflurane analgesia during local anaesthetics injections in in patients awaiting minor surgical procedures.
Secondary ID [1] 285087 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
analgesia 292623 0
minor surgeries 292624 0
Condition category
Condition code
Anaesthesiology 292941 292941 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Methoxyflurane will be given orally to participants before and during injection of local anaesthetic Ropivacaine. Methoxyflurane is self-administered by inhalation through a hand-held whistle shaped inhaler marketed as Penthrox 'Registered Trademark'. All patients are assessed by an anesthesiologist before commencement of the study. Patients are instructed how to use Penthrox 'Registered Trademark' with advice to occlude the aerating hole if they felt they required more analgesia. Pulse oximetry is used throughout the procedure. The anesthesiologist charges the whistle by emptying the entire contents of the bottle of methoxyflurane provided (3 mL) into the bottom of the whistle. Patients are instructed to take some slow easy breaths of the vapour and when they were comfortable with the aroma, take 10 large full breaths, inhaling and exhaling through the whistle. The injection of LA lasts 1 minute and commences after the second breath on Penthrox 'Registered Trademark'. Participants can inhale through the Penthrox 'Registered Trademark' more than 10 times if they feel the need.
Intervention code [1] 289932 0
Treatment: Drugs
Comparator / control treatment
no control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292803 0
Pain levels on the numerical Wong-Baker Faces pain rating scale.
Timepoint [1] 292803 0
1 min after injection of local anaesthetics
Secondary outcome [1] 309702 0
Sedation scores using the Ramsay sedation scale.
Timepoint [1] 309702 0
at 1 min after local anaesthetics injection

Eligibility
Key inclusion criteria
Either sex, more than 18 years old, awaiting minor surgical procedures that can be done under local anaesthetics.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergies to methoxyflurane or local anaesthetics

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289691 0
Self funded/Unfunded
Name [1] 289691 0
Address [1] 289691 0
Country [1] 289691 0
Primary sponsor type
Hospital
Name
Peninsula health
Address
PO box 52
Frankston
VIC 3199
Country
Australia
Secondary sponsor category [1] 288386 0
None
Name [1] 288386 0
Address [1] 288386 0
Country [1] 288386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291434 0
Peninsula Health ethics committee
Ethics committee address [1] 291434 0
Ethics committee country [1] 291434 0
Australia
Date submitted for ethics approval [1] 291434 0
Approval date [1] 291434 0
01/09/2009
Ethics approval number [1] 291434 0

Summary
Brief summary
This pilot study assesses the feasablity and safety of inhaled methoxyflurane in ambulatory plastic surgery procedures as an alternative to intravenous sedation.
Trial website
Trial related presentations / publications
Article submitted for publication, in review.
Public notes

Contacts
Principal investigator
Name 50350 0
Mr David Hunter-Smith
Address 50350 0
Peninsula Health - department of Plastics and Reconstructive surgery
PO box 52
Frankston
Vic 3199
Country 50350 0
Australia
Phone 50350 0
+613 9784 8416
Fax 50350 0
Email 50350 0
dhuntersmith@gmail.com
Contact person for public queries
Name 50351 0
Dr Alexandra Rizzitelli
Address 50351 0
Peninsula Health - department of surgery

PO box 52
Frankston
Vic 3199
Country 50351 0
Australia
Phone 50351 0
+613 9784 8416
Fax 50351 0
Email 50351 0
arizzitelli@phcn.vic.gov.au
Contact person for scientific queries
Name 50352 0
Dr Alexandra Rizzitelli
Address 50352 0
Peninsula Health - department of surgery

PO box 52
Frankston
Vic 3199
Country 50352 0
Australia
Phone 50352 0
+613 9784 8416
Fax 50352 0
Email 50352 0
arizzitelli@phcn.vic.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary