All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia
Conditions
Brief 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.
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.
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5) | 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
| Measure | Time frame | Description |
|---|---|---|
| Ability to complete intended procedure | At procedure visit | Documented by clinic nurse post- procedure |
| Modified Ramsay Sedation score | At procedure visit | Maximal sedation score during procedure documented by clinic nurse |
| Adverse events | At procedure visit and first follow-up visit (within 1 month post-procedure) | Either self- or physician-reported |
| Visual analog pain scale | At procedure visit | Maximal degree of pain during procedure |
Outcome results
None listed