Penthrox in Otolaryngology

N/ANot Yet RecruitingNCT07003880

Sir Mortimer B. Davis - Jewish General Hospital50 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Ability to complete intended procedure

Documented by clinic nurse post- procedure

Time frame: At procedure visit

Modified Ramsay Sedation score

Maximal sedation score during procedure documented by clinic nurse

Time frame: At procedure visit

Adverse events

Either self- or physician-reported

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

Visual analog pain scale

Maximal degree of pain during procedure

Time frame: At procedure visit

Data from ClinicalTrials.gov

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