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

RecruitingPhase 1, Phase 2Ages 19 Years - anyAllSt. Paul's Hospital, Canada
NCT06750302 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 19 years or older * Scheduled for minor sinus surgery or coblation procedures Exclusion Criteria: * 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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What it tests

  • Methoxyflurane - Penthrox
  • Placebo
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Where

1 site
St Paul's Sinus Centre
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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