Trials / Completed
CompletedNCT04029012
Penthrox in Rezūm BPH
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)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Dean Elterman · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open-labeled, single-centre study
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methoxyflurane | Methoxyflurane inhaler before Rezum procedure |
Timeline
- Start date
- 2019-09-10
- Primary completion
- 2020-02-14
- Completion
- 2020-02-14
- First posted
- 2019-07-23
- Last updated
- 2022-01-24
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04029012. Inclusion in this directory is not an endorsement.