Skip to main content
OpenTrials
Completed

NCT Number: NCT04029012

Penthrox in Rezūm BPH

Open-labeled, single-centre study

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Can-Am HIFU Inc

Toronto, Ontario, Canada

About this study

Patients who have elected Convective Thermal Therapy using Rezūm System for the management of their BPH and fulfilled inclusion and exclusion criteria will sign informed consent form for the study. Patient will use Methoxyflurane inhaler (Penthrox™) on top of standard oral analgesia including oral lorazepam, oral Percocet® (oxycodone and acetaminophen) or oxycodone immediate-release, and intra-urethral lidocaine gel (Xylocaine®). Intravenous propofol will be used as rescue analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subjects of ≥ 18 years of age
  • Patient who has elected Convective Thermal Therapy using Rezūm System for the management of their benign prostatic hyperplasia.
  • No contra-indication on using Methoxyflurane inhaler (Penthrox™).
  • Willing and able to accurately complete the required questionnaires.
  • Willing and able to provide signed and dated informed consent.

Exclusion criteria

  • Ongoing use of analgesic agents for chronic pain.
  • Concomitant use of nephrotoxic agents.
  • INR > 4.
  • Use of Methoxyflurane inhaler (Penthrox™) within the previous 3 months.
  • Known allergy to Lorazepam, Percocet/ Oxycodone, or Xylocaine® gel.
  • Known personal or familial hypersensitivity to Methoxyflurane inhaler (Penthrox™) or other halogenated anesthetics.
  • Clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment.
  • An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol.
  • Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
  • A history of liver dysfunction after previous Methoxyflurane inhaler (Penthrox™) use or other halogenated anesthetics.

Treatment and study plan

Methoxyflurane

Drug

Methoxyflurane inhaler before Rezum procedure

Other names: Penthrox

Primary outcomes

  1. Pain intensity

    Time frame: immediately after final injection of Rezūm treatment

    Visual Analog Scale (VAS) from the range of 0-10 (0 represents no pain, 10 represents maximum pain)

Sponsors and collaborators

Lead sponsor

Dean Elterman

Other

Registry information

Official study title

A Pilot Study to Assess Efficacy and Safety of Methoxyflurane for Pain Control During Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2019
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.