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RECRUITING
NCT06750302
PHASE1/PHASE2

Effectiveness of Penthrox vs Placebo in Sinus Procedures, a Clinical Trial

Sponsor: St. Paul's Hospital, Canada

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-11-24

Completion Date

2026-06-24

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DRUG

Methoxyflurane - Penthrox

3ml

OTHER

Placebo

saline + one drop of methoxyflurane

Locations (1)

St Paul's Sinus Centre

Vancouver, British Columbia, Canada