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

NCT06750302 | Recruiting Phase 1 DMC

• 1 other identifier: H24-02351
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale (VAS) for Pain

  This scale measures the intensity of pain experienced by the participant during and immediately after the procedure. Participants will rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable) at various time points: immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure. The primary goal is to compare the pain relief provided by methoxyflurane (Penthrox) versus the placebo.

  Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure.

• Pain Duration

  This measure tracks the duration of pain experienced by the participant post-surgery. This will help assess how long the pain relief from methoxyflurane lasts compared to the placebo.

  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)

  The NPRS will be used as a secondary assessment to quantify the severity of pain. Patients will rate their pain on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The NPRS is a simpler and widely used scale for self-reported pain.

  Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure.

• Amount of Local Anesthetic Injections

  his outcome measures the total number of local anesthetic injections (e.g., lidocaine or bupivacaine) required during the procedure. Fewer injections may indicate better pain control with the study intervention (methoxyflurane) as compared to the placebo. This will help assess the need for additional pain management during surgery.

  Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure.

• Patient Perception of Analgesic Effect

  After the procedure, participants will be asked to report their perception of pain relief and whether they felt the analgesic effect was sufficient during the procedure. The outcome will be assessed through a self-reported survey where participants rate the effectiveness of the pain management on a Likert scale (e.g., from very effective to not effective at all).

  Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure.

Secondary Outcomes (7)

• Type of Procedure

  At surgery time

• Field of View During Surgery

  At surgery time

• Estimated Blood Loss in milliliters

  At surgery time

• SNOT-22 Score

  It will be administered pre-operatively, as well as at 4, 8, and 12 weeks post-op

• APAIS Score (Anxiety and Pain Assessment)

  Pre-operative

Study Arms (2)

Penthrox

ACTIVE COMPARATOR

3mL Penthrox as an inhaled analgesic

Drug: Methoxyflurane - Penthrox

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Methoxyflurane - Penthrox DRUG

3ml

Penthrox

Placebo OTHER

saline + one drop of methoxyflurane

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years or older
• Scheduled for minor sinus surgery or coblation procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

St Paul's Sinus Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Central Study Contacts

Amin Javer, MD

CONTACT

604-806-9926; sinusdoc@me.com

Leonora Beltran, MD

CONTACT

604-806-9926; lbeltranjimenez@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 27, 2024
• Study Start: November 24, 2024
• Primary Completion: April 24, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: May 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)