Penthrox in Otolaryngology

NCT07003880 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: 2025-4462
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our objective is to explore the use of methoxyflurane anesthesia as an adjunct analgesic to local anesthesia during in-office otolaryngology procedures in a prospective pilot study. The main outcome of this study will be patient satisfaction with the medication and analgesia. Secondary outcomes will include level of sedation and analgesia, patient-reported post-procedural pain levels, and any reported adverse events.

Conditions

All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5)

  This is a validated 14-item including Likert scales and dichotomous (yes/no) items on the effectiveness, side effects, convenience and global satisfaction with the medication taken

  At first follow-up visit (within 1 month post-procedure)

Secondary Outcomes (4)

• Ability to complete intended procedure

  At procedure visit

• Modified Ramsay Sedation score

  At procedure visit

• Adverse events

  At procedure visit and first follow-up visit (within 1 month post-procedure)

• Visual analog pain scale

  At procedure visit

Study Arms (1)

Patients undergoing an otolaryngology in-office procedure using methoxyflurane

All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia: * Skin lesion excision or reconstruction * Fine or core needle aspiration biopsy * Mucosal biopsy * Laryngeal injection or biopsy * Myringotomy with or without tympanostomy tube insertion * Inferior turbinate reduction * Septal button insertion

Drug: Methoxyflurane anesthesia

Interventions

Methoxyflurane anesthesia DRUG

A single Penthrox (3mL) self-inhaler will be administered 5-minutes prior to the onset of the procedure, before local anesthesia. Patients will undergo the procedure, have post-procedural vital signs, and remain in clinic for observation for 30 minutes post-procedure per our usual post-procedure monitoring.

Patients undergoing an otolaryngology in-office procedure using methoxyflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients undergoing an otolaryngology proceure in the Otolaryngology clinic of the Jewish General Hospital with inhaled methoxyflurane as an adjunct to topical or local anesthesia

You may qualify if:

• All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia:
• Skin lesion excision or reconstruction
• Fine or core needle aspiration biopsy
• Mucosal biopsy
• Laryngeal injection or biopsy
• Myringotomy with or without tympanostomy tube insertion
• Inferior turbinate reduction
• Septal button insertion

You may not qualify if:

• Patient unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)
• Presence of any contraindications to inhaled methoxyfluorane per product monograph:
• Patients less than 18 years of age
• Pregnancy, intended pregnancy, or current breast-feeding
• Inadequate patient understanding or lack of cooperation
• Decreased level of consciousness or head injury
• History of clinically significant renal impairment, e.g., reduced renal output
• History of liver dysfunction following previous exposure to halogenated anesthetics
• Current use of tetracycline antibiotics
• Personal or genetic history of malignant hyperthermia
• Muscular dystrophy

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-04