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Not yet recruitingNCT07003880PenthroxOTLUpdated Jun 4, 2025

Penthrox in Otolaryngology

An observational study in All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia, sponsored by Sir Mortimer B. Davis - Jewish General Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Sir Mortimer B. Davis - Jewish General Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 50 is below the median of 65 across 184 observational studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital is the lead sponsor of 61 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugMethoxyflurane 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.

06

What researchers measure

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

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

Secondary outcomes

  1. Ability to complete intended procedure

    Documented by clinic nurse post- procedure

    Time frame: At procedure visit

  2. Modified Ramsay Sedation score

    Maximal sedation score during procedure documented by clinic nurse

    Time frame: At procedure visit

  3. Adverse events

    Either self- or physician-reported

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

  4. Visual analog pain scale

    Maximal degree of pain during procedure

    Time frame: At procedure visit

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07003880
Lead sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Responsible party
Sponsor
First posted
Jun 4, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jun 4, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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