All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local AnesthesiaPenthroxOTLNCT07003880
Penthrox in Otolaryngology
An observational study of All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia, run by Sir Mortimer B. Davis - Jewish General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia
- What is being tested?
- Methoxyflurane anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: Inhaled Methoxyflurane for In-Office Procedures 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.
- Being tested
- Methoxyflurane anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxyflurane anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Methoxyflurane anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At first follow-up visit (within 1 month post-procedure)
Secondary outcomes (4)
Ability to complete intended procedure
Documented by clinic nurse post- procedure
Measured: At procedure visit
Modified Ramsay Sedation score
Maximal sedation score during procedure documented by clinic nurse
Measured: At procedure visit
Adverse events
Either self- or physician-reported
Measured: At procedure visit and first follow-up visit (within 1 month post-procedure)
Visual analog pain scale
Maximal degree of pain during procedure
Measured: At procedure visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003880
- Sponsor's protocol ID
- 2025-4462
- Acronym
- PenthroxOTL
- Status last verified
- Apr 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Methoxyflurane for In-Office Procedures in Otolaryngology
- ClinicalTrials.gov ID
- NCT07003880
- Acronym / sponsor ID
- PenthroxOTL / 2025-4462
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing an otolaryngology in-office procedure using methoxyflurane | – | Drug: Methoxyflurane anesthesiaAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia:
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methoxyflurane anesthesiaA 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. | Drug | Patients undergoing an otolaryngology in-office procedure using methoxyflurane |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia, run by Sir Mortimer B. Davis - Jewish General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5) (time frame: At first follow-up visit (within 1 month post-procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.