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Trial registered on ANZCTR
Registration number
ACTRN12618001849280
Ethics application status
Approved
Date submitted
8/11/2018
Date registered
14/11/2018
Date last updated
26/04/2019
Date data sharing statement initially provided
14/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A multi-centre Retrospective, Comparative, Observational Study in Australia and New Zealand to Evaluate the Safety of repeated administration of PENTHROX® (methoxyflurane) for the treatment of Acute Pain associated with Burns and Wound Care Management
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Scientific title
A multi-centre Retrospective, Comparative, Observational Study in Australia and New Zealand to Evaluate the Safety of repeated administration of PENTHROX® (methoxyflurane) for the treatment of Acute Pain associated with Burns and Wound Care Management
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Secondary ID [1]
296548
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Nil known
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Universal Trial Number (UTN)
U1111-1223-6046
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute pain
310329
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Drug safety
310331
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Condition category
Condition code
Injuries and Accidents
309061
309061
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0
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Burns
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Injuries and Accidents
309062
309062
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0
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Other injuries and accidents
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Anaesthesiology
309078
309078
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0
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Pain management
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Patients enrolled in the study have been prescribed no less than four (4) doses of methoxyflurane for the treatment of acute pain associated with the management of burns or wound injuries.
Safety data, including adverse event data, will be collected retrospectively from medical records completed as part of in-patient management, with data being from clinical notes and laboratory assessments entered into medical records from the time of each methoxyflurane administration up to 24 hours from each dose.
Data relating to the safety of methoxyflurane will be collected for up to 28 days from the first dose of methoxyflurane to determine the type, occurrence and severity of adverse events as recorded in the medical records that may indicate a possible relationship with methoxyflurane use.
An additional evaluation period of 28-days from the last dose of methoxyflurane is intended to collect data specific to adverse events of special interest.
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Intervention code [1]
312857
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Diagnosis / Prognosis
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Comparator / control treatment
Patients admitted to approved study sites who have been prescribed no less than four (4) doses of analgesics (nitrous oxide or short acting opioids) for the treatment of acute pain.
Data from up to 250 patients will be retrospectively collected from medical records at approved study sites.
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Control group
Active
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Outcomes
Primary outcome [1]
308034
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Occurrence of adverse events in the first 24-hours following methoxyflurane administration versus a non-methoxyflurane treated comparator group using patient medical records
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Assessment method [1]
308034
0
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Timepoint [1]
308034
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Up to 28-days from first methoxyflurane dose or to time of discharge
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Primary outcome [2]
308081
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Rate of adverse events of special interest (AESI), specifically acute kidney injury, and acute hepatic failure reported in patient medical records
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Assessment method [2]
308081
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Timepoint [2]
308081
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From date of first administration up to 28-days after the final methoxyflurane administration
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Secondary outcome [1]
353747
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Evaluation of the frequency of adverse events reported in hospital medical records for patients who had received multiple administration of methoxyflurane for the management of acute pain as compared to a comparator group
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Assessment method [1]
353747
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Timepoint [1]
353747
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Up to 28-days from final methoxyflurane dose or till time of discharge
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Secondary outcome [2]
353830
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Evaluation of the type and frequency of adverse events reported by system order class relative to the number of methoxyflurane administrations as recorded in patient medical records
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Assessment method [2]
353830
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Timepoint [2]
353830
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Up to 28-days from final methoxyflurane dose or till time of discharge
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Secondary outcome [3]
353897
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Evaluation of the severity of adverse events reported in hospital medical records for patients who had received multiple administration of methoxyflurane for the management of acute pain as compared to a comparator group
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Assessment method [3]
353897
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Timepoint [3]
353897
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Up to 28-days from final methoxyflurane dose or till time of discharge
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Eligibility
Key inclusion criteria
• Males and females, aged greater than or equal to 18 years.
• Patients who are hospital inpatients or managed through outpatient services for the treatment and management of burns or wound injury and require analgesia for the treatment of acute pain
• Patients whose burn’s coverage is less than 18% of body surface area as determined using the ‘Wallace Rules of Nines’ method (or equivalent)
• For methoxyflurane group - A minimum of 4 methoxyflurane doses for the treatment of acute pain associated with the management of burns or wound injury (including a minimum of two doses in the first 7 days and the other doses from Day 8 onwards) until methoxyflurane treatment cessation up to 28 days or to time of discharge
• For comparator group - A minimum of 4 doses of analgesic (e.g. nitrous oxide or short acting opioids) for the treatment of acute pain associated with the management of burns or wound injury (including a minimum of two doses in the first 7 days and the other doses from Day 8 onwards) until analgesic treatment cessation up to 28 days or until time of discharge.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Less than the minimum of 4 methoxyflurane or other short acting analgesic doses for the treatment of acute pain associated with the management of burns or wound injury (including a minimum of two doses in the first 7 days and the other doses from Day 8 onwards
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
In general, continuous data will be summarised by treatment group using the following descriptive statistics: n, mean, standard deviation, median, minimum and maximum. Categorical data will be summarised by treatment group as the number and percentage of Subjects in each category
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
Sponsor decision to cancel study
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Date of first participant enrolment
Anticipated
14/01/2019
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Actual
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Date of last participant enrolment
Anticipated
29/04/2019
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Actual
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Date of last data collection
Anticipated
29/04/2019
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
301127
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Commercial sector/Industry
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Name [1]
301127
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Mundipharma Research Ltd
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Address [1]
301127
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Unit 194, Cambridge Science Park, Milton Road Cambridge, CB4 0AB
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Country [1]
301127
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United Kingdom
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Primary sponsor type
Commercial sector/Industry
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Name
Plunkett Consulting Group
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Address
171 Union Road, Surrey Hills VIC 3127
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Country
Australia
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Secondary sponsor category [1]
300750
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None
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Name [1]
300750
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Address [1]
300750
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Country [1]
300750
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301879
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Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
301879
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Westmead Research Office
Research & Education Network bldg
Westmead Hospital
Darcy Road
Westmead 2145 NSW
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Ethics committee country [1]
301879
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Australia
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Date submitted for ethics approval [1]
301879
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15/08/2018
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Approval date [1]
301879
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03/12/2018
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Ethics approval number [1]
301879
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Summary
Brief summary
The study is a multi-site, comparator, retrospective, observational study to evaluate the safety of repeated dosing of methoxyflurane for the treatment of acute pain. The study will collect clinical laboratory and observational data to characterise the safety of methoxyflurane. A comparator group of non-methoxyflurane treated patients with burns or wound injuries will be included to further determine adverse events that may be associated with methoxyflurane administration.
All relevant data will be collected from patients admitted to study hospitals for the treatment and management of burns or other wound injuries that will require interventions that may cause pain and/or discomfort and require analgesia for the management of acute pain.
Patients included in the methoxyflurane group will have been administered no less than 4 doses of methoxyflurane, including a minimum of 2 doses in the first 7 days. The comparator group will have received analgesia (such as nitrous oxide) for treatment of acute pain. Particular emphasis will be directed toward those patients who have received a larger number of doses for a longer time period, as these patients may be considered at higher risk of an adverse event occurring.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Alan Bullingham
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Address
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Blacktown Hospital
8 Blacktown Rd,
Blacktown NSW 2148
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Country
88414
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Australia
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Phone
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+61 2 9881 8000
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Fax
88414
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Email
88414
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[email protected]
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Contact person for public queries
Name
88415
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Mr Greg Plunkett
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Address
88415
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Plunkett Consulting Group
171 Union Road
Surrey HIlls VIC 3127
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Country
88415
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Australia
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Phone
88415
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+61 398986353
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Fax
88415
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Email
88415
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[email protected]
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Contact person for scientific queries
Name
88416
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Mr Greg Plunkett
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Address
88416
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Plunkett Consulting Group
171 Union Road
Surrey HIlls VIC 3127
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Country
88416
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Australia
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Phone
88416
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+61 398986353
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Fax
88416
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Email
88416
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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