Penthrox for Sinusitis

Overseen By Leonora Beltran, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: St. Paul's Hospital, Canada

Disqualifiers: Cystic fibrosis, Bleeding disorders, Renal failure, others

Compensation: Varies

Number of Visits: 4

Duration: 1 day

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Penthrox (methoxyflurane) for sinusitis?

Methoxyflurane, used in Penthrox, has been shown to be effective for pain relief in trauma and during procedures like colonoscopy, suggesting it may help manage pain associated with sinusitis. Its fast-acting and easy-to-use nature makes it a promising option for quick pain relief. ^{1 2 3 4 5}

How does the drug Penthrox (methoxyflurane) differ from other treatments for sinusitis?

Penthrox (methoxyflurane) is unique because it is an inhaled analgesic, allowing patients to self-administer and control their pain relief, which is different from typical oral or injectable medications. Its fast onset and ease of use make it particularly suitable for situations requiring rapid pain management, although its use for sinusitis is not yet widespread. ^{1 2 3 4 5}

What is the purpose of this trial?

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

This trial is for patients with sinusitis undergoing minor sinus procedures. Participants must be able to inhale the study substance and complete pain and anxiety assessments. Specific inclusion or exclusion criteria are not provided, but typically would involve age, health status, and no contraindications for Penthrox.

Inclusion Criteria

I am 19 years old or older.

I am scheduled for a minor sinus surgery.

Exclusion Criteria

I have experienced changes in my awareness due to head injury, alcohol, or drug use.

I have never had severe liver disease or liver failure.

I have a bleeding disorder or systemic vasculitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants inhale 3 mL of Penthrox or placebo during their sinus procedure. Pain and anxiety are assessed using VAS and APAIS scores.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points post-operatively.

12 weeks

3 visits (in-person) at 4, 8, and 12 weeks

Treatment Details

Interventions

• Methoxyflurane - Penthrox

Trial Overview The trial tests if inhaled methoxyflurane (Penthrox) is more effective than a placebo at relieving pain during minor sinus procedures. It's a randomized controlled trial where participants unknowingly receive either Penthrox or a placebo while their pain relief and anxiety levels are measured.

Participant Groups

Group I: Penthrox Active Control 1 Intervention

3mL Penthrox as an inhaled analgesic

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

St. Paul's Hospital, Canada

Lead Sponsor

Trials

48

Recruited

13,200+

Findings from Research

Inhaled methoxyflurane (Penthrox) is as effective as intravenous midazolam and fentanyl for managing pain during colonoscopy, with similar pain and anxiety scores reported by patients in both groups.

Patients using Penthrox experienced quicker recovery times and no respiratory depression, allowing them to be discharged earlier compared to those receiving conventional sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-controlled analgesia with inhaled methoxyflurane versus conventional endoscopist-provided sedation for colonoscopy: a randomized multicenter trial. Nguyen, NQ., Toscano, L., Lawrence, M., et al.[2022]

Methoxyflurane, delivered via the Penthrox autoinhaler, is a promising analgesic for emergency settings due to its fast onset, safety, and ease of use, yet its adoption in Europe remains limited despite its potential benefits.

This systematic review aims to evaluate the efficacy of inhaled methoxyflurane compared to placebo and standard care in acute trauma, focusing on patient-reported pain relief within the first 30 minutes and assessing the risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled methoxyflurane (Penthrox) for analgesia in trauma: a systematic review protocol. Eager, MM., Nolan, GS., Tonks, K., et al.[2022]

Methoxyflurane, once discontinued in North America due to nephrotoxicity concerns, has been successfully reintroduced as a safe inhaled analgesic for pain relief in over 37 countries, particularly in prehospital settings.

The Penthrox inhaler allows patients to self-administer methoxyflurane, providing conscious sedation and effective pain control with minimal side effects when used at recommended doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reincarnation of Methoxyflurane. Ikeda, S.[2020]

A study conducted in two hospital emergency departments in France found that nurses experienced very low levels of occupational exposure to methoxyflurane, with a median concentration of only 0.017 ppm during 8-hour shifts, which is nearly 900 times lower than the maximum exposure limit of 15 ppm.

There was no correlation between the number of methoxyflurane applications administered and the exposure levels measured, suggesting that the use of this inhaled analgesic is safe for healthcare providers in terms of occupational exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-interventional study evaluating exposure to inhaled, low-dose methoxyflurane experienced by hospital emergency department personnel in France. Frangos, J., Belbachir, A., Dautheville, S., et al.[2021]

In a study of 140 patients with morbid obesity or obstructive sleep apnea, inhaled methoxyflurane (Penthrox) was found to be a safe and effective analgesic during colonoscopy, with no respiratory depression and a significantly lower incidence of hypotension and respiratory desaturation compared to anesthesia-assisted deep sedation (AADS).

Penthrox not only reduced procedural time and recovery time but also resulted in lower costs, making it a preferred option for patients, with 90% expressing willingness to use it again for future procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable inhaled methoxyflurane is feasible and safe for colonoscopy in subjects with morbid obesity and/or obstructive sleep apnea. Nguyen, NQ., Toscano, L., Lawrence, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-controlled analgesia with inhaled methoxyflurane versus conventional endoscopist-provided sedation for colonoscopy: a randomized multicenter trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Inhaled methoxyflurane (Penthrox) for analgesia in trauma: a systematic review protocol. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Reincarnation of Methoxyflurane. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Non-interventional study evaluating exposure to inhaled, low-dose methoxyflurane experienced by hospital emergency department personnel in France. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Portable inhaled methoxyflurane is feasible and safe for colonoscopy in subjects with morbid obesity and/or obstructive sleep apnea. [2022]