Actively Recruiting

Phase 1
Phase 2
Age: 19Years +
All Genders
NCT06750302

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

Led by St. Paul's Hospital, Canada · Updated on 2025-05-15

100

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 years or older
  • Scheduled for minor sinus surgery or coblation procedures
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St Paul's Sinus Centre

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

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Research Team

A

Amin Javer, MD

CONTACT

L

Leonora Beltran, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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