Trial Review

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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
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
Secondary ID [1] 296548 0
Nil known
Universal Trial Number (UTN)
U1111-1223-6046
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute pain 310329 0
Drug safety 310331 0
Condition category
Condition code
Injuries and Accidents 309061 309061 0 0
Burns
Injuries and Accidents 309062 309062 0 0
Other injuries and accidents
Anaesthesiology 309078 309078 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 312857 0
Diagnosis / Prognosis
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.
Control group
Active

Outcomes
Primary outcome [1] 308034 0
Occurrence of adverse events in the first 24-hours following methoxyflurane administration versus a non-methoxyflurane treated comparator group using patient medical records
Timepoint [1] 308034 0
Up to 28-days from first methoxyflurane dose or to time of discharge
Primary outcome [2] 308081 0
Rate of adverse events of special interest (AESI), specifically acute kidney injury, and acute hepatic failure reported in patient medical records
Timepoint [2] 308081 0
From date of first administration up to 28-days after the final methoxyflurane administration
Secondary outcome [1] 353747 0
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
Timepoint [1] 353747 0
Up to 28-days from final methoxyflurane dose or till time of discharge
Secondary outcome [2] 353830 0
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
Timepoint [2] 353830 0
Up to 28-days from final methoxyflurane dose or till time of discharge
Secondary outcome [3] 353897 0
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
Timepoint [3] 353897 0
Up to 28-days from final methoxyflurane dose or till time of discharge

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Sponsor decision to cancel study
Date of first participant enrolment
Anticipated
14/01/2019
Actual
Date of last participant enrolment
Anticipated
29/04/2019
Actual
Date of last data collection
Anticipated
29/04/2019
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301127 0
Commercial sector/Industry
Name [1] 301127 0
Mundipharma Research Ltd
Country [1] 301127 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Plunkett Consulting Group
Address
171 Union Road, Surrey Hills VIC 3127
Country
Australia
Secondary sponsor category [1] 300750 0
None
Name [1] 300750 0
Address [1] 300750 0
Country [1] 300750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301879 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301879 0
Westmead Research Office
Research & Education Network bldg
Westmead Hospital
Darcy Road
Westmead 2145 NSW
Ethics committee country [1] 301879 0
Australia
Date submitted for ethics approval [1] 301879 0
15/08/2018
Approval date [1] 301879 0
03/12/2018
Ethics approval number [1] 301879 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88414 0
Dr Alan Bullingham
Address 88414 0
Blacktown Hospital
8 Blacktown Rd,
Blacktown NSW 2148
Country 88414 0
Australia
Phone 88414 0
+61 2 9881 8000
Fax 88414 0
Email 88414 0
[email protected]
Contact person for public queries
Name 88415 0
Greg Plunkett
Address 88415 0
Plunkett Consulting Group
171 Union Road
Surrey HIlls VIC 3127
Country 88415 0
Australia
Phone 88415 0
+61 398986353
Fax 88415 0
Email 88415 0
[email protected]
Contact person for scientific queries
Name 88416 0
Greg Plunkett
Address 88416 0
Plunkett Consulting Group
171 Union Road
Surrey HIlls VIC 3127
Country 88416 0
Australia
Phone 88416 0
+61 398986353
Fax 88416 0
Email 88416 0
[email protected]

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?

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.