None listed
Conditions
Brief summary
The purpose of this study is to see if the discomfort of a prostate biopsy can be reduced by a drug called methoxyflurane (Penthrox) given with a simple inhaler, popularly known as the ‘green whistle’, and widely used by ambulance officers and first aid services. Methoxyflurane is already approved in Australia for the relief of pain in patients having surgical procedures. Who is it for? You may be eligible to participate in this study if you are a male, aged 18 or over, who has been scheduled for your first transrectal ultrasound-guided prostate biopsy. Study Details All participants have injections of a local anaesthetic (lignocaine) around their prostate before the biopsy. This is the standard way of reducing the discomfort of a prostate biopsy. Before having the local anaesthetic, all participants are given the study treatment which is a ‘green whistle’ inhaler after being shown how to use it. After their biopsy, participants fill out short, simple forms to let us know how they felt. In this study, one half of the participants are given inhalers loaded with methoxyflurane (the active inhaler group). The other half are given inhalers that look and smell the same, but are loaded with saline solution alone (the placebo inhaler group). Comparing the results in these two groups at the end of the study will show how good methoxyflurane is at reducing the discomfort of a prostate biopsy. It is hoped that this study will improve understanding of drugs which may be used to reduce discomfort of prostate biopsies for future patients.
Interventions
Inhaled methoxyflurane, provided as a commercial pack of one Penthrox (Registered Trademark) Inhaler, containing 3mL methoxyflurane, of which participants choose how many puffs they feel they need.
Administration will commence approximately one minute before insertion of the rectal probe.
To use the inhaler, the patient will put their lips around the mouthpiece and take normal sized breaths as required. Participants may choose to inhale throughout the entire procedure, however will only receive
Inhaled methoxyflurane, provided as a commercial pack of one Penthrox (Registered Trademark) Inhaler, containing 3mL methoxyflurane, of which participants choose how many puffs they feel they need. Administration will commence approximately one minute before insertion of the rectal probe. To use the inhaler, the patient will put their lips around the mouthpiece and take normal sized breaths as required. Participants may choose to inhale throughout the entire procedure, however will only receive one pack, and therefore a maximum of 3mL methoxyflurane. All participants will subsequently receive standard therapy (PILA) as standard of care. PILA consists of periprostatic injections of approximately 2.5mL of 2% lignocaine into each of the two sides of the base of the prostate gland at the junction of the seminal vesicle, using a 23g needle, administered about 5 minutes before doing the first biopsy. The Pharmacy Department will maintain a record of drugs dispensed for each participant as well as a record of drug receipt and drug destruction as appropriate.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males older than 18 years scheduled to undergo a TRUS biopsy of the prostate. 2. No history of significant liver disease 3. No history of significant renal disease 4. Willing and able to complete questionnaires in English 5. Willing and able to undergo TRUS biopsy within 7 days of randomisation 6. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments 7. Signed, written informed consent
Exclusion criteria
1. Previous TRUS biopsy of the prostate 2. Personal or family history of malignant hyperthermia 3. Hypersensitivity to fluorinated anaesthetics or other inhalational anaesthetics 4. Concurrent use of barbiturates or tetracycline antibiotics 5. Concurrent illness that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety 6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
Outcome results
None listed