None listed
Conditions
Brief summary
Cophenylcaine (a combination of lignocaine and phenylephrine, a local anaesthetic and decongestant respectively) is commonly used as a spray to make the inside of the nose numb in Otolaryngology (ear, nose and throat surgery) clinics. However, other local anaesthetics like tetracaine are more potent than lignocaine, and phenylephrine tastes very bitter whereas other decongestants like oxymetazoline are essentially tasteless. Our hypothesis is that using a tetracaine/oxymetazoline spray instead of cophenylcaine will make nasal endoscopy more comfortable. We will enrol participants from tertiary rhinology (sinus and nose surgery) clinics who are having nasal endoscopy as a part of their care. Tetracaine/oxymetazoline will be sprayed in one nostril and cophenylcaine will be sprayed in the other. This will be randomised and neither the participant nor the specialist performing endoscopy will know which spray was used on which side. Both the participants and the specialists will fill out simple questionnaires after nasal endoscopy the comfort of the procedure on each side and the tolerability of the sprays themselves. This will help to determine whether people find nasal endoscopy more comfortable with tetracaine/oxymetazoline, and whether clinicians prefer tetracaine/oxymetazoline over cophenylcaine for topical anaesthesia prior to nasal endoscopy.
Interventions
The intervention will be one of the following. The dose combination deemed to provide the quickest time to effective anaesthesia based on the results of a preceding study (ACTRN12622001123730) will be used.
Tetracaine 0.5% + oxymetazoline 0.05% spray (1 mg tetracaine, 0.1 mg oxymetazoline)
Tetracaine 1% + oxymetazoline 0.05% spray (2 mg tetracaine, 0.1 mg oxymetazoline)
Tetracaine 2% + oxymetazoline 0.05% spray (4 mg tetracaine, 0.1 mg oxymetazoline)
Participants will be randomised to receive
The intervention will be one of the following. The dose combination deemed to provide the quickest time to effective anaesthesia based on the results of a preceding study (ACTRN12622001123730) will be used. Tetracaine 0.5% + oxymetazoline 0.05% spray (1 mg tetracaine, 0.1 mg oxymetazoline) Tetracaine 1% + oxymetazoline 0.05% spray (2 mg tetracaine, 0.1 mg oxymetazoline) Tetracaine 2% + oxymetazoline 0.05% spray (4 mg tetracaine, 0.1 mg oxymetazoline) Participants will be randomised to receive the intervention spray in one nasal cavity and cophenylcaine (control) in the other nasal cavity. Participants will therefore serve as their own controls. Sprays will be given by an investigator (either a specialist or advanced trainee in Otolaryngology Head and Neck Surgery) prior to nasal endoscopy in a tertiary rhinology clinic. This will be given at a set time prior to endoscopy based on the time to effective anaesthesia determined in the previous study (ACTRN12622001123730). Sprays will be administered in the head-forward position. 0.2 mL of the intervention spray will be given intranasally. Additional 0.1 mL sprays may be given up to a maximum of 5 sprays if required for further decongestion or anaesthesia during endoscopy. Maximum possible drug doses given will therefore be 10 mg tetracaine and 0.25 mg oxymetazoline.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Age 18-75 years Able and willing to provide informed consent to participate Requires rigid nasal endoscopy as a routine part of a clinic appointment
Exclusion criteria
Unable to provide informed consent, or non-consenting Known hypersensitivity to constituents of the test solutions Pregnancy Acute unwellness Smoking
Outcome results
None listed