Effectiveness of Penthrox vs Placebo in Sinus Procedures, a Clinical Trial
The Effectiveness of Inhaled Methoxyflurane (Penthrox) vs Placebo for Pain Relief in Coblation and Sinus Procedures: a Double-blind, Randomized, Placebo - Controlled Trial
St. Paul's Hospital, Canada
100 participants
Nov 24, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Age 19 years or older
- Scheduled for minor sinus surgery or coblation procedures
Exclusion Criteria10
- 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
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Interventions
3ml
saline + one drop of methoxyflurane
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06750302