Penthrox in Otolaryngology

Not yet recruiting

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

• Registration Number: NCT07003880
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Study Start: 2025-06-01
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2027-05-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing an otolaryngology in-office procedure using methoxyflurane	Methoxyflurane anesthesia	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

Primary Outcome Measures

Name	Time	Method
TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5)	At first follow-up visit (within 1 month post-procedure)	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

Secondary Outcome Measures

Name	Time	Method
Modified Ramsay Sedation score	At procedure visit	Maximal sedation score during procedure documented by clinic nurse
Adverse events	At procedure visit and first follow-up visit (within 1 month post-procedure)	Either self- or physician-reported
Visual analog pain scale	At procedure visit	Maximal degree of pain during procedure
Ability to complete intended procedure	At procedure visit	Documented by clinic nurse post- procedure