Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001146785
Ethics application status
Approved
Date submitted
16/08/2022
Date registered
22/08/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
22/08/2022
Date results provided
8/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Finding a better nasal anaesthetic: the efficacy of tetracaine and oxymetazoline as a topical nasal anaesthetic and decongestant for people having nasal endoscopy
Scientific title
The efficacy of tetracaine and oxymetazoline as a topical nasal anaesthetic and decongestant for people having nasal endoscopy
Secondary ID [1] 307765 0
Nil known
Universal Trial Number (UTN)
U1111-1281-5559
Trial acronym
Linked study record
This is a follow-up study to ACTRN12622001123730

Health condition
Health condition(s) or problem(s) studied:
Nasal endoscopy 327363 0
Condition category
Condition code
Anaesthesiology 324486 324486 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324258 0
Treatment: Drugs
Comparator / control treatment
Cophenylcaine (5% lignocaine + 0.5% phenylephrine) nasal spray

0.2 mL of this preparation will be given intranasally to one nasal cavity as a spray (10 mg lignocaine, 1 mg phenylephrine). 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 25 mg lignocaine and 2.5 mg phenylephrine.
Control group
Active

Outcomes
Primary outcome [1] 332280 0
Difference in subjectively reported comfort of nasal endoscopy between nasal cavities anaesthetised with cophenylcaine or tetracaine/oxymetazoline, using a 100mm visual analogue scale.
Timepoint [1] 332280 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Primary outcome [2] 332346 0
Local anaesthetic systemic toxicity is a rare adverse event and all doses of local anaesthetic given in this study are well below the doses required to cause toxicity. If this was to occur, however, it would be detected by onset of symptoms and signs during the clinic appointment. Initial symptoms such as perioral numbness will be reported by the patient, confirmed by clinical assessment by the specialist, and managed by the same specialist. This will be documented in the questionnaire completed by the specialist and reported to the Centre for Adverse Reactions Monitoring (New Zealand Pharmacovigilance Centre). This questionnaire has been developed specifically for this study.
Timepoint [2] 332346 0
During the clinic appointment (within ten minutes of application of intervention and control sprays)
Secondary outcome [1] 412791 0
Difference between overall comfort of application of each anaesthetic/decongestant spray (cophenylcaine and tetracaine/oxymetazoline), using a 100mm visual analogue scale.
Timepoint [1] 412791 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [2] 413052 0
Sensation of throat numbness using a 5 point Likert scale
Timepoint [2] 413052 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [3] 413053 0
Difference between sides in sensation of maxillary dental numbness using a 5 point Likert scale
Timepoint [3] 413053 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [4] 413054 0
Difference in sensation of nasal airflow between sides, using a 5 point Likert scale
Timepoint [4] 413054 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [5] 413055 0
Overall which spray was preferred by the patient (as indicated by side - left/right/neither). This data will be collected by a single item question designed specifically for this study.
Timepoint [5] 413055 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [6] 413056 0
Difference in clinician perception of patient comfort between sides, using 100 mm VAS for each side
Timepoint [6] 413056 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [7] 413057 0
Clinician perception of which spray decongested the nose more effectively, as indicated by side (left/right/neither). This data will be collected by a single item question designed specifically for this study.
Timepoint [7] 413057 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [8] 413058 0
Clinician perception of which nasal cavity was easier to instrument, as indicated by side (left/right/neither). This data will be collected by a single item question designed specifically for this study.
Timepoint [8] 413058 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [9] 413059 0
Differences in number of additional sprays required between sides. This data will be recorded in response to a specific question regarding the number of sprays given on each side in the questionnaire filled out by the clinician. This questionnaire was designed specifically for this study.
Timepoint [9] 413059 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)
Secondary outcome [10] 413060 0
Which spray the examining clinician preferred overall, as indicated by side (left/right/neither). This data will be collected by a single item question designed specifically for this study.
Timepoint [10] 413060 0
Immediately following the clinic appointment at which nasal endoscopy was performed (approximately ten minutes after endoscopy and intervention sprays)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent, or non-consenting
Known hypersensitivity to constituents of the test solutions
Pregnancy
Acute unwellness
Smoking

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The nasal sprays will be randomised to left or right nasal cavities by an investigator not involved in recruitment or treatment and the bottles will be marked as "left" or "right" with all other markings on the bottles obscured.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analyses were conducted using R v4.1.1 “Kick Things” (R Core Team, Vienna, Austria).

Assuming that a 10 mm difference between means with a standard deviation of 10 mm of the difference in the VAS for the primary outcome is clinically significant, 15 participants would be required to identify a significant difference between groups using a paired t-test (alpha = 0.05, 1 - beta = 0.95). These numbers are based on previous studies that have reported their results without all necessary information to produce these power calculations. 20 patients will therefore be recruited to mitigate the potential weakening effect of the assumptions made when basing these power calculations on those studies.

Statistical analyses will be performed with the assistance of a statistician using a standard statistical software package. Demographics will be summarised using descriptive measures. Interventions will be compared using appropriate statistical tests following analysis for normality of distribution of the data.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Interim analysis after data collection from ten participants indicated no statistical or clinical difference between sprays for the primary outcomes, and no trend was observed that might suggest recruitment of more participants would change that.
Date of first participant enrolment
Anticipated
5/09/2022
Actual
18/05/2023
Date of last participant enrolment
Anticipated
31/03/2023
Actual
26/05/2023
Date of last data collection
Anticipated
31/03/2023
Actual
26/05/2023
Sample size
Target
20
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 24960 0
New Zealand
State/province [1] 24960 0
Auckland

Funding & Sponsors
Funding source category [1] 312035 0
Charities/Societies/Foundations
Name [1] 312035 0
The Garnett Passe and Rodney Williams Memorial Foundation
Country [1] 312035 0
Australia
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 313537 0
None
Name [1] 313537 0
Address [1] 313537 0
Country [1] 313537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311451 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 311451 0
Ethics committee country [1] 311451 0
New Zealand
Date submitted for ethics approval [1] 311451 0
02/03/2022
Approval date [1] 311451 0
13/07/2022
Ethics approval number [1] 311451 0
2022 FULL 11767

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121138 0
Prof Richard Douglas
Address 121138 0
University of Auckland
Faculty of Medical and Health Sciences
Building 507
20-33 Park Avenue
Grafton, 1023
Auckland
Country 121138 0
New Zealand
Phone 121138 0
+64 9 923 9820
Fax 121138 0
Email 121138 0
[email protected]
Contact person for public queries
Name 121139 0
Sam Hale
Address 121139 0
University of Auckland
Faculty of Medical and Health Sciences
Building 507
20-33 Park Avenue
Grafton, 1023
Auckland
Country 121139 0
New Zealand
Phone 121139 0
+64 9 9239820
Fax 121139 0
Email 121139 0
[email protected]
Contact person for scientific queries
Name 121140 0
Sam Hale
Address 121140 0
University of Auckland
Faculty of Medical and Health Sciences
Building 507
20-33 Park Avenue
Grafton, 1023
Auckland
Country 121140 0
New Zealand
Phone 121140 0
+64 9 9239820
Fax 121140 0
Email 121140 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.