Comparing Penthrox to placebo for pain relief in sinus procedures
The Effectiveness of Inhaled Methoxyflurane (Penthrox) vs Placebo for Pain Relief in Coblation and Sinus Procedures: a Double-blind, Randomized, Placebo - Controlled Trial
PHASE1; PHASE2 · St. Paul's Hospital, Canada · NCT06750302
This study is testing if inhaling Penthrox can help people feel less pain during minor sinus procedures compared to a placebo.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | St. Paul's Hospital, Canada (other) |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06750302 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial evaluates the effectiveness of inhaled methoxyflurane (Penthrox) as an analgesic for patients undergoing minor sinus and rhinology procedures, such as Endoscopic Sinus Surgery (ESS) and coblation. Participants will inhale either Penthrox or a placebo during their procedure and will be assessed for pain relief using the Visual Analog Scale (VAS), as well as for anxiety and complications. The study aims to determine if Penthrox provides superior pain relief compared to placebo, potentially improving patient comfort during these procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years or older scheduled for minor sinus surgery or coblation procedures.
Not a fit: Patients with conditions such as cystic fibrosis, severe kidney or liver disease, or those with a history of respiratory depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and effective pain management option for patients undergoing minor sinus procedures.
How similar studies have performed: Previous studies have shown promising results for methoxyflurane in acute pain management, but its use in minor surgical procedures is less explored, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vancouver, British Columbia
- St Paul's Sinus Centre — Vancouver, British Columbia, Canada (RECRUITING)
Study contacts
- Study coordinator: Amin Javer, MD
- Email: sinusdoc@me.com
- Phone: 604-806-9926
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Rhinosinusitis, Sinus Surgery, Endoscopic Sinus Surgery, Coblation, Methoxyflurane, Penthrox, Inhaled Analgesic, Inhaled Analgesics in Rhinology