None listed
Conditions
Brief summary
This study will assess the feasibility of giving methoxyflurane to patients with advanced cancer during a single episode of incidental cancer pain (IcP) in the palliative care setting, with a particular focus on regional and rural populations. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced cancer, you have used a palliative care service previously and you are scheduled to undergo a procedure/event considered likely by clinical staff to induce IcP. Potential examples include radiotherapy, malignant wound dressing, or personal hygiene activities. Study details All participants who choose to enrol in this study will be asked to undergo a procedure/event considered likely by clinical staff to induce IcP at a palliative care centre. Immediately following the event, participants will be given a methoxyflurane inhaler (also known as the 'green whistle') and asked to breathe in and out using the inhaler as needed to achieve adequate analgesia, using the minimum effective dose. Participants will be asked to rate their pain levels before they use the inhaler and will be assessed at 20 and 60 minutes after using the inhaler and within 60-90 minutes post procedure completion. Participants will also be asked to report any side effects that they experience after using the inhaler, for up to 90 minutes post procedure completion. It is hoped this research will demonstrate that use of a methoxyflurane inhaler can provide effective immediate pain relief to patients with advanced cancer who experience incidental cancer-related pain episodes. If this initial study is successful, a larger study involving a greater number of patients with advanced cancer may be conducted.
Interventions
evaluating methoxyflurane as an acceptable alternative to standard care in managing single episode Incidental Cancer Pain in palliative care.
Each participant will be given one inhaler loaded with one dose (3 mL) of methoxyflurane. If the participant continues to experience clinically significant pain during the same procedure after the first dose, a second dose (3 mL) may be provided, at the discretion of the supervising healthcare practitioner (HCP). Any second dose will be administered only d
evaluating methoxyflurane as an acceptable alternative to standard care in managing single episode Incidental Cancer Pain in palliative care. Each participant will be given one inhaler loaded with one dose (3 mL) of methoxyflurane. If the participant continues to experience clinically significant pain during the same procedure after the first dose, a second dose (3 mL) may be provided, at the discretion of the supervising healthcare practitioner (HCP). Any second dose will be administered only during the same procedure, after the first inhaler has been used, with a maximum total dose of 6 mL for that procedure. All participants will be under the supervision of an HCP appropriately trained in the administration technique. The trained HCP will assist the participant with the self-administration of methoxyflurane inhaler for the duration of the procedure.
Sponsors
Latrobe Regional Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients with advanced cancer who are known to a palliative care service and meet the pre-specified inclusion and exclusion criteria. Patients will be scheduled to undergo a procedure/event considered likely by clinical staff to induce IcP and require the use of a rapid onset/offset analgesic agent. Potential examples include radiotherapy, malignant wound dressing, or personal hygiene activities. • Age 18 years or older. • Diagnosis of advanced cancer. • Known to a palliative care service. • Undergoing a procedure felt by clinical staff likely to induce IcP requiring the use of a rapid onset/offset analgesic agent. • Capacity to provide written informed consent. • Be able to use a methoxyflurane inhaler device. • Have had a recent measurement of renal and liver function within the preceding two weeks (or be able to undergo venipuncture for this purpose).
Exclusion criteria
• Clinically significant cardiac or respiratory disease, where associated with cardiovascular instability or respiratory depression. • Personal or family history of adverse reactions to methoxyflurane (or any volatile anaesthetic). • Personal or family history of malignant hyperthermia. • Altered consciousness defined as Glascow Coma Scale < 13. • Impaired renal function (defined as eGFR <45), or receiving nephrotoxic antibiotics (e.g. tetracycline, gentamicin, colistin, polymyxin B or amphotericin B). • Liver disease resulting in AST/ALT elevation above 3 times the upper limit of normal (ULN), or elevation of bilirubin above 2 times the upper limit of normal (unless hyperbilirubinaemia is explained by a diagnosis of Gilbert's syndrome). • Taking CYP-450 enzyme inducers (e.g. alcohol, isoniazid, phenobarbital or rifampicin). • Dosing expected to exceed the acceptable dosing of Methoxyflurane (no more than two ampules,3mL each, per episode).
Outcome results
None listed