Penthrox in Otolaryngology (PenthroxOTL)

Sir Mortimer B. Davis - Jewish General Hospital

Status: Not yet enrolling

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

Treatments: Drug: Methoxyflurane anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT07003880

2025-4462

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

50 participants in 1 patient group

Patients undergoing an otolaryngology in-office procedure using methoxyflurane

Description:

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

Treatment:

Drug: Methoxyflurane anesthesia