NCT06750302 Effectiveness of Penthrox vs Placebo in Sinus Procedures, a Clinical Trial
| NCT ID | NCT06750302 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | St. Paul's Hospital, Canada |
| Condition | Chronic Rhinosinusitis (CRS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-24 |
| Primary Completion | 2026-04-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-11-24 with a primary completion date of 2026-04-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06750302 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Chronic Rhinosinusitis (CRS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06750302 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06750302 currently recruiting?
Yes, NCT06750302 is actively recruiting participants. Contact the research team at sinusdoc@me.com for enrollment information.
Where is the NCT06750302 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT06750302 clinical trial?
NCT06750302 is sponsored by St. Paul's Hospital, Canada. The trial plans to enroll 100 participants.