Penthrox in Otolaryngology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methoxyflurane anesthesia.
- Who it may be relevant to
- Registry conditions: All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Inhaled Methoxyflurane for In-Office Procedures in Otolaryngology
Overview
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.
Interventions
- Drug Methoxyflurane anesthesia
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.
Primary outcome measures
- TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5) [Time frame: At first follow-up visit (within 1 month post-procedure)]
Secondary outcome measures (4)
- Ability to complete intended procedure [Time frame: At procedure visit]
- Modified Ramsay Sedation score [Time frame: At procedure visit]
- Adverse events [Time frame: At procedure visit and first follow-up visit (within 1 month post-procedure)]
- Visual analog pain scale [Time frame: At procedure visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07003880 · 2025-4462