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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called methoxyflurane (Penthrox) to determine if it better relieves pain during minor sinus surgeries compared to a placebo. The goal is to assess whether Penthrox alleviates pain, reduces anxiety, and causes fewer complications, such as bleeding. Participants will inhale either Penthrox or a placebo during their procedure and provide feedback on their pain and anxiety levels. It suits those scheduled for minor sinus surgeries, like coblation, who do not have conditions such as cystic fibrosis or severe liver disease. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that methoxyflurane, the main ingredient in Penthrox, has undergone safety testing in several studies. One study with adults using methoxyflurane for pain relief found that 42.2% of participants experienced side effects such as dizziness and headache, the most commonly reported ones.

Patients should know that methoxyflurane is already approved for pain relief in other contexts, indicating a known safety record. The current trial remains in its early stages, so researchers are closely monitoring safety. However, its existing use suggests it might be safe for sinus procedures as well. Patients should always consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Penthrox for sinusitis because it offers a novel approach to pain relief with its active ingredient, methoxyflurane. Unlike standard treatments such as antibiotics or decongestants that primarily address infection or congestion, Penthrox is administered as an inhaled analgesic, providing quick pain management directly through inhalation. This delivery method is unique and allows for rapid absorption and relief, which could be especially beneficial for patients seeking immediate pain relief from sinusitis discomfort. Additionally, its use as an inhaled analgesic makes it different from oral or topical painkillers typically used in sinusitis treatment, potentially offering a more targeted approach.

What evidence suggests that Penthrox might be an effective treatment for sinusitis?

Research has shown that methoxyflurane, the active ingredient in Penthrox, effectively relieves pain during medical procedures such as treating injuries and performing colonoscopies. Studies have found that it works quickly and is easy to use, making it a good choice for managing pain. Early results suggest it might also help reduce pain during minor sinus procedures. Methoxyflurane blocks pain signals in the brain, which may explain its effectiveness. While specific data for sinusitis is still being collected in this trial, its success in other areas is encouraging. Participants in this trial will receive either Penthrox or a placebo to evaluate its effectiveness for sinusitis. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06750302?term=AREA%5BInterventionSearch%5D(PENTHROX)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=7

Effectiveness of Penthrox vs Placebo in Sinus Procedures ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06750302/effectiveness-of-penthrox-vs-placebo-in-sinus-procedures-a-clinical-trial

Effectiveness of Penthrox vs Placebo in Sinus Procedures ... This randomized, double-blind, placebo-controlled trial aims to assess the efficacy of methoxyflurane (Penthrox) as an inhaled analgesic for patients ...

3. withpower.com withpower.com/trial/phase-2-rhinosinusitis-10-2024-6d650

Penthrox for Sinusitis · Recruiting Participants for Phase ... 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 ...

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06750302/

Trial | NCT06750302 The goal of this randomized controlled trial is to evaluate the effectiveness of inhaled methoxyflurane (Penthrox) as an analgesic for patients undergoing ...

5. studies.bethecure.ca studies.bethecure.ca/find/0001094c7a644a04b8eb96416409180d5a9058a9-the-effectiveness-of-inhaled-methoxyflurane-pen

Effectiveness of Penthrox vs Placebo in Sinus Procedures, a ... The goal of this randomized controlled trial is to evaluate the effectiveness of inhaled methoxyflurane (Penthrox) as an analgesic for patients undergoing minor ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5083764/

Methoxyflurane Analgesia in Adult Patients in the Emergency ... Treatment-related adverse events (mostly dizziness/headache) were reported by 42.2% of patients receiving methoxyflurane and 14.9% of patients ...

7. mdpi.com mdpi.com/2227-9032/9/10/1360

Methoxyflurane in Non-Life-Threatening Traumatic Pain— ... Most patients had a low prehospital severity score. The median pain at arrival on site was 8 and the overall decrease in pain observed was 4.2 (95% CI 3.9–4.5).