Recruiting
Phase 1
Phase 2

Penthrox

Sponsor:

St. Paul's Hospital, Canada

Code:

NCT06750302

Conditions

Chronic Rhinosinusitis (CRS)

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Methoxyflurane - Penthrox

Placebo

Study Details

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.

Conditions

Chronic Rhinosinusitis (CRS)

Study ID

NCT06750302

Start date

Nov 24, 2024

Status verified date

Dec, 2024

Completion date

Jun 24, 2026

Anticipated

Primary completion date

Apr 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Penthrox

3mL Penthrox as an inhaled analgesic

placebo comparator: Placebo

3mL placebo control (saline + one drop of methoxyflurane)

Interventions

Methoxyflurane - Penthrox

3ml

Placebo

saline + one drop of methoxyflurane

Primary outcome measure

  • Visual Analog Scale (VAS) for Pain [ Time Frame: Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure. ]
  • Pain Duration [ Time Frame: It will be recorded as the time (in minutes or hours) from the end of the procedure until the participant reports no significant pain in a time frame of 4 hours ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure. ]
  • Amount of Local Anesthetic Injections [ Time Frame: Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure. ]
  • Patient Perception of Analgesic Effect [ Time Frame: Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure. ]

Central Contacts and Locations

Locations

St Paul's Sinus Centre

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

More Information

Sponsor

St. Paul's Hospital, Canada

Last update posted

May 15, 2025

Last verified

Dec, 2024

Keywords

  • Chronic Rhinosinusitis (CRS)
  • Sinus Surgery
  • Endoscopic Sinus Surgery (ESS)
  • Coblation
  • Methoxyflurane
  • Penthrox
  • Inhaled Analgesic
  • Inhaled Analgesics in Rhinology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Paul's Hospital, Canada on 2025-05-15.