Prospective double blind randomised controlled study comparing patient experience and analgesia, between methoxyflurane (Penthrox®) vs placebo for patients requiring interventional radiological procedures

South Western Sydney Local Health District Human Research Ethics Committee0 个研究点目标入组 400 人开始时间: 2023年11月10日最近更新: 2023年11月20日

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•All patients undergoing deep tissue biopsy and insertion or removal of portacaths in the Liverpool Hospital Interventional Radiology Department will be offered participation in the study. Methoxyflurane is routinely used as an adjunct to local anaesthesia for these procedures in our department. Patients 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 and afebrile.
•deep tissue biopsies
•portacath insertions
•portacath removal
•able to consent
•hemodynamically stable

•Low acuity outpatient procedures have deliberately been selected for the purposes of this study. These typically require low levels of sedation. Patients who require definite IV sedation, who are pregnant or in whom it is not appropriate to blind to no sedation will be excluded from the study.
•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. Any patient with allergy or prior adverse reaction to methoxyflurane will not be given methoxyflurane and therefore excluded from the study.
•Patients with impaired renal function (eGFR<50) or liver dysfunction will be excluded as per standard of care for the safe administration of Penthrox® based on the Australia Medical Handbook, Liverpool Hospital protocol and the Australian Therapeutic Goods Administration.
•renal impairment (eGFR<50)
•liver dysfunction
•opt out or refusal
•definite IV sedation required
•clinically inappropriate to blind to possibility of no additional analgesic adjunct

发起方

South Western Sydney Local Health District Human Research Ethics Committee