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NCT Number: NCT07003880

Penthrox in Otolaryngology

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5)

    Time frame: 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 outcomes

  1. Ability to complete intended procedure

    Time frame: At procedure visit

    Documented by clinic nurse post- procedure

  2. Modified Ramsay Sedation score

    Time frame: At procedure visit

    Maximal sedation score during procedure documented by clinic nurse

  3. Adverse events

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

    Either self- or physician-reported

  4. Visual analog pain scale

    Time frame: At procedure visit

    Maximal degree of pain during procedure

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Official study title

Inhaled Methoxyflurane for In-Office Procedures in Otolaryngology

Acronym: PenthroxOTL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.