drugset / Trial / NCT06750302

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

NCT06750302

Phase 1/2 Recruiting 100 enrolled St. Paul's Hospital, Canada
RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start
2024-11-24
Primary completion
2026-04-24
Completion
2026-06-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methoxyflurane Small molecule 3 ml Inhaled