Effectiveness of Penthrox vs Placebo in Sinus Procedures, a Clinical Trial
RecruitingPhase 1, Phase 2NCT06750302
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Brief summary (from the registry)
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.
Study details
- Official title
- The Effectiveness of Inhaled Methoxyflurane (Penthrox) vs Placebo for Pain Relief in Coblation and Sinus Procedures: a Double-blind, Randomized, Placebo - Controlled Trial
- Conditions
- Chronic Rhinosinusitis (CRS)
- Interventions
- Drug: Methoxyflurane - Penthrox
- Other: Placebo
- Sponsor
- St. Paul's Hospital, Canada
- Start date
- 2024-11-24
- Primary completion
- 2026-04-24
- Sex
- All
- Age range
- from 19 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age 19 years or older * Scheduled for minor sinus surgery or coblation procedures Exclusion Criteria: * 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
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| St Paul's Sinus Centre | Vancouver | British Columbia |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06750302