A Study Comparing Inhaled Methoxyflurane Penthrox to Placebo for Pain Relief During Minor Sinus and Coblation Procedures

What this Trial Is About

Researchers are evaluating the effectiveness of inhaled methoxyflurane Penthrox as a pain relief option for patients undergoing minor sinus and rhinology procedures, such as sinus surgery and coblation. This randomized, double-blind, placebo-controlled trial compares Penthrox to a placebo to determine if it provides better pain relief, reduces anxiety, and leads to fewer complications like bleeding. The study aims to improve patient comfort by offering a non-invasive alternative to local anesthetic injections during these common office-based procedures. Participants will inhale either 3 mL of methoxyflurane or a placebo solution saline with one drop of methoxyflurane to mimic the smell through a self-administered inhaler immediately before and during their procedure. The trial includes two groups of about 50 patients each, with random assignment stratified by procedure type. Pain, anxiety, and complications will be measured at various times during and after the treatment. During the study, participants will complete pain assessments using the Visual Analog Scale VAS and anxiety evaluations using the APAIS score before and after their procedures. Researchers will monitor for bleeding, adverse events, and other complications immediately after, 1 hour, and 24 hours post-procedure. Sinus symptoms and quality of life will be followed up using SNOT-22 scores at 4, 8, and 12 weeks. The total participation period includes the procedure day and follow-up visits over several weeks.

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