Penthrox in Otolaryngology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Methoxyflurane for IUD Insertion and Endometrial Biopsy

NCT07046572

Endometrial Biopsy Intrauterine Devices

RECRUITING NA

Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage

NCT03872700

Abscess

COMPLETED PHASE3

Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

NCT02653742

Pain, Postoperative Otitis Media

UNKNOWN PHASE4

Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media

NCT02092454

Pain Acute Otitis Media

COMPLETED PHASE2

Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults

NCT02410707

Joint Dislocation Perianal Abscess Abscess

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Methoxyflurane anesthesia

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No