The primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during Rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (BPH). We propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ICH Guidelines for Good Clinical Practice as well the regulations set by the Biomedical Research Ethics Board, University of Manitoba.
Able to provide an informed consent.
Age ≥ 18 years
Biological males identified with male sexual organs.
Scheduled for convective radiofrequency water vapor thermal therapy (REZUM) for the management of benign prostate hyperplasia.
Concomitant use of nephrotoxic and/or hepatoxic agents.
Use of ≥ 6 ml Penthrox withing the previous 3 weeks.
Known allergies and/or adverse events due to penthrox, other halogenated anesthetics, percocet (oxycodone + acetaminophen), lorazepam, lidocaine, midazolam, ketamine, remifentanil and propofol
History of genetic susceptibility to malignant hyperthermia.
Parallel
Methoxyflurane - Penthrox
DrugPenthrox is a brand name for a drug called methoxyflurane. It is an inhaled analgesic (pain-relieving) agent used primarily for the relief of moderate to severe pain, typically in emergency medical situations or during minor medical procedures. Penthrox is administered by inhaling the vapors through a hand-held inhaler device. It acts quickly to provide pain relief and has a relatively short duration of action.
Control
Other interventionThis intervention will be the control group only, receiving deep IV sedation.
Percocet Pill
DrugPercocet will be given in conjunction with methoxyfluorane and lorazepam
Lorazepam (drug)
DrugLorazepam will be given in conjunction with penthrox and percocet.
Post-Procedural Pain
Post procedural pain measured using the Numeric Rating Scale for pain. Higher scores on this measurement indicate worser outcomes. Maximum value of 10 and a minimum value of 10 can be reported on this scale.
Safety of Procedure
The safety of combination vs deep intravenous sedation during Rezum will be measured by accounting for adverse event encountered during the procedure.
Cost-effectiveness,
We will compare the costs associated with the procedure in both arms to see if there is any difference.
Anxiety levels
We will measure anxiety levels using the Amsterdam Pre-Operative Anxiety and Information Scale (APAIS). Higher scores indicate worser outcomes. Maximum value of 30 and a minimum value of 0. It is a 6 part questionnaire which each question is given on a likert scale from 1-5
Patient satisfaction
We will measure patient satisfaction using a likert scale single question patient satisfaction questionnaire. (higher scores indicate better outcomes). Maximum value of 5 and a minimum value of 0.
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