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Trial registered on ANZCTR


Registration number
ACTRN12619001493134p
Ethics application status
Submitted, not yet approved
Date submitted
17/09/2019
Date registered
29/10/2019
Date last updated
29/10/2019
Date data sharing statement initially provided
29/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effect of an anaesthetic spray and an anaesthetic spray with additional flavouring in providing anaesthesia for nasendoscopy
Scientific title
A randomised, cross-over clinical trial to evaluate the equivalence of a reformulated Co-phenylcaine spray incorporating taste masking and flavouring agents as compared to the currently marketed Co-phenylcaine Forte spray in providing anaesthesia for nasendoscopy procedures
Secondary ID [1] 299281 0
None
Universal Trial Number (UTN)
U1111-1240-2088
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
ENT conditions requiring nasopharyngeal examination 314414 0
Nasopharyngeal examination 314560 0
Intubation 314561 0
Nasoendoscopy 314562 0
Condition category
Condition code
Oral and Gastrointestinal 312756 312756 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 312897 312897 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Co-Phenylcaine Forte local anaesthetic spray. 100 ul spray containing 5 mg lignocaine hydrochloride and 0.5 mg phenylephrine. 5 sprays administered by ENT surgeon per nostril. The anaesthetic spray will be administered 10 minutes prior to nasendoscopy.

Cross over with wash out period of 4-6 weeks.
Intervention code [1] 315563 0
Treatment: Drugs
Comparator / control treatment
Co-Phenylcaine Forte local anaesthetic spray. 100 ul spray containing 5 mg lignocaine hydrochloride and 0.5 mg phenylephrine with the addition of taste masking and flavouring agents, 5 sprays administered per nostril administered by ENT surgeon. The anaesthetic spray will be administered 10 minutes prior to nasendoscopy.
There will be a 4-6 week crossover period.between trials.
Control group
Active

Outcomes
Primary outcome [1] 321384 0
100 mm Visual analogue scale rating of discomfort (no discomfort: maximum possible discomfort).
Timepoint [1] 321384 0
Immediately after nasendoscopy procedure
Secondary outcome [1] 374834 0
100 mm Visual Analogue Scale rating of pain (no pain: maximum possible pain).
Timepoint [1] 374834 0
Immediately after nasendoscopy procedure
Secondary outcome [2] 374835 0
Likert scale rating of anaesthetic spray taste (like extremely to dislike extremely).
Timepoint [2] 374835 0
Immediately after the local anaesthetic spray is administered.
Secondary outcome [3] 375142 0
Likert scale rating of anaesthetic spray after taste (like extremely to dislike extremely).
Timepoint [3] 375142 0
5 min after the anaesthetic spray has been administered.

Eligibility
Key inclusion criteria
Patients attending an Ear nose and throat (ENT) practice for nasendoscopy examination and minor surgical procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
significant oral disease or injury, any known impairment of taste function and any history of cardiac, liver or kidney conditions.

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)
Numbered/coded spray containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated random number sequence.
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
Cross over trial in which all participants receive both interventions for procedures carried out with a 4-6 week crossover period.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Poisson models for discrete data will be run on the pain and discomfort data. 95 % Confidence intervals (CI) around the model estimates will be compared to ensure that the CI for the Co-Phenylcaine Neo values lies within the 10% equivalence margin for the Co-Phenylcaine Forte values. If there is a predominance of zero values in the data we will use a zero inflated Poisson model. Taste data will be analysed using t-tests or equivalent non-parametric tests (Mann-Witney U test) if the data do not meet the assumptions of normality.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/11/2019
Actual
Date of last participant enrolment
Anticipated
20/01/2020
Actual
Date of last data collection
Anticipated
24/02/2020
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 28030 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 303813 0
Government body
Name [1] 303813 0
Department of Industry, Innovation and Science
Country [1] 303813 0
Australia
Funding source category [2] 303814 0
Commercial sector/Industry
Name [2] 303814 0
ENT Technologies Pty Ltd
Country [2] 303814 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987, Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 303937 0
None
Name [1] 303937 0
Address [1] 303937 0
Country [1] 303937 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304328 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 304328 0
Curtin University, GPO Box U 1987, Perth, WA 6845
Ethics committee country [1] 304328 0
Australia
Date submitted for ethics approval [1] 304328 0
26/08/2019
Approval date [1] 304328 0
Ethics approval number [1] 304328 0

Summary
Brief summary
The objective of this study will be to compare the effectiveness of the currently marketed Co-phenylcaine Forte spray with a reformulated Co-phenylcaine spray incorporating taste masking and flavouring agents (Co-Phenylcaine Neo spray), when administered intra-nasally, in a group of patients undergoing nasendoscopy. The study will be an equivalence trail (10% equivalence margin) using a randomised, blinded, cross-over design with participants undergoing two nasendoscopy procedures approximately 4 weeks apart. Participants will be asked to rate the taste associated with the spray and rate any pain or discomfort they feel following insertion of the nasendoscope. It is hypothesised that both interventions will have an equivalent effect in reducing discomfort and the new formulation will have a preferred taste.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96558 0
Prof Anthony Wright
Address 96558 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 96558 0
Australia
Phone 96558 0
+61401103476
Fax 96558 0
Email 96558 0
T.Wright@curtin.edu.au
Contact person for public queries
Name 96559 0
Anthony Wright
Address 96559 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 96559 0
Australia
Phone 96559 0
+61401103476
Fax 96559 0
Email 96559 0
T.Wright@curtin.edu.au
Contact person for scientific queries
Name 96560 0
Anthony Wright
Address 96560 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 96560 0
Australia
Phone 96560 0
+61401103476
Fax 96560 0
Email 96560 0
T.Wright@curtin.edu.au

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


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.