None listed
Conditions
Brief summary
Procedures performed in interventional radiology are often quick and minimally invasive, however some procedures traditionally require increased pain relief and sedation than local anaesthetic alone. For these procedures, we have previously used intravenous medications (midazolam and fentanyl) for sedation and pain relief; however, dosing of these medications is controlled by your nurse or doctor which can lead to under or over dosing of medications, or delayed pain relief due to delays in administration of medication. We believe that letting the patient control how much medication and how often can be effective.
Interventions
Prospective randomised double arm study comparing methoxyflurane vs intravenous fentanyl and midazolam for patients requiring periprocedural analgesia or sedation.
Penthrox® (1 ampule of 3ml methoxyflurane administered via the “green whistle”) plus local anaesthetic. Patients will be educated on safe use of the “green whistle” and be able to use it for the duration of the procedure.
Sponsors
South Western Sydney Local Health District Human Research Ethics Committee
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients requiring periprocedural analgesia or sedation above local anaesthesia alone for procedures in the Liverpool Hospital Interventional Radiology Department will be offered participation in the study. Participants must be over 18 years of age and have capacity to provide consent. Written informed voluntary consent will be obtained. Patients must be hemodynamically stable. Expected procedure time must be under 2 hours. able to consent for procedure and participation in research patients requiring periprocedural analgesia or sedation above local anaesthesia alone hemodynamically stable expected procedure time <2h over 18 years of age
Exclusion criteria
The research project will be discussed with the patients at the time of consent. It will be clearly explained that they may opt out of the study or deny/withdraw consent at any stage. Patients unable to provide informed, voluntary, competent consent will be excluded. Similarly, if a sufficient understanding or communication cannot be established, including NESB/CALD, the patient will need to be excluded from the study and included in the discussion/exclusions analysis. Any patient with allergy or prior adverse reaction to methoxyflurane, midazolam or fentanyl will be excluded from the study. Patients requiring general anaesthesia or formal support by anaesthetist (e.g. needing intubation) will also be excluded. Patients with impaired renal function (eGFR<50) or liver dysfunction will be excluded due to the random possibility of receiving methoxyflurane as per standard of care for the safe administration of methoxyflurane based on the Australia Medical Handbook, Liverpool Hospital protocol and the Australian Therapeutic Goods Administration. renal impairment (eGFR<50) liver dysfunction pregnancy opt out or refusal requiring general anaesthesia or formal support by anaesthetist (e.g. needing intubation) prior allergy or adverse reaction to methoxyflurane, midazolam or fentanyl
Outcome results
None listed