Effectiveness of Penthrox vs Placebo in Sinus Procedures, a Clinical Trial
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Chronic Rhinosinusitis (CRS)
In brief
The goal of this randomized controlled trial is to evaluate the effectiveness of inhaled methoxyflurane (Penthrox) as an analgesic for patients undergoing minor rhinology and sinus procedures, specifically comparing it to a placebo control. The primary question the study aims to answer is: Does methoxyflurane provide superior pain relief compared to placebo during minor sinus procedures, as measured by the Visual Analog Scale (VAS)? If there is a comparison group: Researchers will compare the effects of Penthrox to the placebo (saline + one drop of methoxyflurane) to see if it provides better pain relief, reduces anxiety, and leads to fewer complications, including bleeding. Participants will be asked to: Inhale 3 mL of Penthrox or placebo during their procedure. Complete a VAS scale to assess pain. Complete anxiety assessments pre- and post-operatively. Be monitored for complications such as bleeding and other adverse effects. This study will help determine the effectiveness of Penthrox as a non-invasive, quick-acting analgesic for minor sinus surgeries.
Key facts
- Study ID
- NCT06750302
- Run by
- St. Paul's Hospital, Canada
- People needed
- 100
- Starts
- 2024-11-24
- Expected to finish
- 2026-06-24
- Last updated by the study team
- 2025-05-15
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 19 years or older
- Scheduled for minor sinus surgery or coblation procedures
You may not qualify if…
- Cystic fibrosis
- Systemic vasculitis or other bleeding disorders
- History of renal failure or severe kidney disease
- History of liver failure or severe liver disease
- Altered state of consciousness (head injury, alcohol use, drug use)
- Known or suspected hypersensitivity to lidocaine or sensorcaine
- Inhaled drug use (i.e., cocaine) in the preceding 6 months
- Nasal tumors
- Personal or family history of malignant hyperthermia
- Respiratory depression
Where it is running
- St Paul's Sinus Centre — Vancouver, British Columbia, Canada (enrolling)
Full record on ClinicalTrials.gov
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