Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Scheduled for minor sinus surgery or coblation procedures
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
Trial Site Locations
Total: 1 location
1
St Paul's Sinus Centre
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
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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