Methoxyflurane + Lorazepam + Percocet for Enlarged Prostate

Overseen By Premal Patel, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of Manitoba

Must not be taking: Nephrotoxic, Hepatoxic agents

Disqualifiers: Respiratory, Cardiovascular, Renal, Hepatic, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an oral combination of methoxyflurane, lorazepam, and Percocet can provide pain relief comparable to deep IV sedation during treatment for benign prostate hyperplasia (BPH), an enlarged prostate. Participants will either use this oral combination or receive standard IV sedation to manage pain during the Rezum procedure, a convective radiofrequency water vapor thermal therapy. Men scheduled for Rezum treatments for BPH who can provide informed consent may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially new standard of care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using drugs that harm the kidneys or liver. If you have used more than 6 ml of Penthrox in the last 3 weeks, you cannot join the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methoxyflurane, also known as Penthrox, is generally safe for patients. Studies have found it easy to use and effective in quickly relieving pain during medical procedures like Rezum therapy for an enlarged prostate. Most patients reported satisfaction with its use. This treatment is in the final stages of testing, indicating it has already passed earlier safety tests. While it is likely safe, ongoing studies will provide further insights. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of methoxyflurane, lorazepam, and Percocet for treating enlarged prostate because it offers a potentially more comfortable experience during the REZUM procedure. Unlike the standard deep IV sedation, this approach allows patients to start using methoxyflurane, also known as Penthrox, just 10 minutes before the procedure, thanks to its quick onset time of about 5 minutes. This could mean less waiting time and potentially fewer side effects compared to traditional sedation methods, making the procedure smoother and more efficient for patients.

What evidence suggests that this trial's treatments could be effective for benign prostate hyperplasia?

Research has shown that methoxyflurane (Penthrox), which participants in this trial may receive, effectively relieves pain during Rezum therapy, a treatment for an enlarged prostate. Studies report that most patients were satisfied with the pain relief, with satisfaction rates ranging from 63% to over 98%. Methoxyflurane acts quickly, often within minutes, making it a suitable option for easing discomfort during the procedure. Overall, early evidence supports its use as a safe and effective method for managing pain in this treatment. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for men with benign prostatic hyperplasia (enlarged prostate) who require Rezum therapy. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.

Inclusion Criteria

Able to provide an informed consent

I am scheduled for a REZUM procedure for my enlarged prostate.

I am 18 years old or older.

Exclusion Criteria

Altered level of consciousness due to any cause.

I am not taking any medication that is harmful to my kidneys or liver.

I have a genetic risk for malignant hyperthermia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Procedure Preparation

Participants in the experimental arm receive a single 'per os' dose of percocet and lorazepam, and education on using the Penthrox inhaler. Control arm receives deep IV sedation.

30 minutes

1 visit (in-person)

Procedure

Participants undergo Rezum convective radiofrequency water vapor thermal therapy. Pain and anxiety levels are measured.

1 day

1 visit (in-person)

Immediate Post-Procedure

Self-reported pain is recorded using the NRS. A phone call follow-up is conducted the following day to record any adverse events.

1 day

Follow-up

A phone call follow-up is conducted four weeks post-procedure to assess patient satisfaction and any adverse events.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Convective Radiofrequency Water Vapor Thermal Therapy (REZUM)

Trial Overview The study tests if a combination of methoxyflurane, lorazepam, and Percocet taken orally provides similar pain relief during Rezum therapy as deep intravenous sedation. It's a single-center, randomized controlled trial without blinding to compare these analgesia methods.

How Is the Trial Designed?

Group I: Intervention arm-Penthrox Experimental Treatment 3 Interventions

Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes

Group II: Control arm Placebo Group 1 Intervention

Patients will receive standard of care during their rezum procedure which consists of deep IV sedation.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36495576/

Efficacy and safety of methoxyflurane (Penthrox) for pain ... Results: Ten patients were recruited. Median prostate volume was 53.4 cc (range 24-158 cc). Patients received a median of 10.5 Rezum injections, with a median ...

2. canjurol.com canjurol.com/html/free-articles/2022/29-06/Cdn_JU29-I6_08_FREE_DrEltermanS.pdf

Efficacy and safety of methoxyflurane (Penthrox) for pain ... Introduction: The safety and efficacy of low dose methoxyflurane disposable inhaler (Penthrox) was assessed in this study of men undergoing Rezum water.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11836836/

Inhaled methoxyflurane (Penthrox) use in the outpatient and ... Similarly, the NRSIs showed variable results. Most patients were satisfied (63% to >98%; seven studies) with Penthrox, and seven out of eight ...

4. iasp-pain.org iasp-pain.org/efficacy-and-safety-of-methoxyflurane-penthrox-for-pain-control-during-water-vapor-thermal-therapy-rezum-for-benign-prostatic-enlargement/

Efficacy and safety of methoxyflurane (Penthrox) for pain ... Efficacy and safety of methoxyflurane (Penthrox) for pain control during water vapor thermal therapy (Rezum) for benign prostatic enlargement.

5. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/2/e089031.full.pdf

Inhaled methoxyflurane (Penthrox) use in the outpatient ... Efficacy and safety of methoxyflurane (Penthrox) for pain control during water vapor thermal therapy (Rezum) for benign prostatic enlargement.