None listed
Conditions
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.
Interventions
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
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.
Sponsors
Plunkett Consulting Group
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed