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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Moffett’s solution cause greater post-operative throat pain compared to Co-phenylcaine in sinonasal surgery?
Scientific title
A comparison of post-operative throat pain in patients prepared with Moffett's solution versus Co-phenylcaine in sinonasal surgery.
Secondary ID [1] 298172 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic rhinosinusitis 312735 0
nasal obstruction 312736 0
post-operative pain 312738 0
Condition category
Condition code
Surgery 311234 311234 0 0
Other surgery
Respiratory 311274 311274 0 0
Other respiratory disorders / diseases

Study type
Description of intervention(s) / exposure
The intervention-arm (twenty patients) were decongested with Moffett’s solution (The solution consisted of a mixture of 2mL of 10% cocaine solution (200mg), 1mL of 1:1000 adrenaline, 2mL of sodium bicarbonate and 5mL of 0.9% sodium chloride solution, 10mL in total with 5mL applied to each side). The Moffett's solution will be administered immediately prior to surgery by atomiser nasal spray.
The control-arm (ten patients) with Co-phenylcaine, which will also be administered immediately prior to surgery by nasal nozzles spray. There solutions are both routinely used by Ear Nose and Throat surgeons in Australia.
Intervention code [1] 314424 0
Treatment: Drugs
Comparator / control treatment
The control-arm (ten) was prepared with Co-phenylcaine, consisting of 5% lignocaine hydrochloride (50mg/ml, total 25mg) and 0.5% phenylephrine hydrochloride (5mg/ml, total 2.5mg) delivered using the provided atomised spray nozzle, five sprays per side (100 microlitre per spray) 10 minutes prior to surgery.
Control group

Primary outcome [1] 319991 0
Post-operative throat pain measured by 10 point VAS.
Timepoint [1] 319991 0
1st day post-operatively
Secondary outcome [1] 370117 0
post-operative throat pain measured by 10 point VAS.
Timepoint [1] 370117 0
second day post-operatively

Key inclusion criteria
Patients undergoing routine sinonasal surgery (septoplasty, turbinate surgery, functional endoscopic sinus surgery) requiring nasal preparation.
Minimum age
15 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients with a history of previous sinonasal surgery were excluded from the study.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Statistical analysis was performed using Stata version 14.0 (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP.) and a P-value <0.05 was considered statistically significant. Continuous, parametric variables were presented as means with standard deviations, while categorical variables were presented as percentages. Comparison of VAS scores was performed using a student’s unpaired t-test. Comparison of potential airway confounders between groups was performed using Fisher’s exact test.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 13699 0
Westmead Hospital - Westmead
Recruitment hospital [2] 13700 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 26391 0
2145 - Westmead
Recruitment postcode(s) [2] 26392 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 302707 0
Name [1] 302707 0
Department of otolaryngology, Westmead Hospital
Address [1] 302707 0
Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145 Sydney, New South Wales.
Country [1] 302707 0
Primary sponsor type
Department of otolaryngology, Westmead Hospital
Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145 Sydney, New South Wales.
Secondary sponsor category [1] 302635 0
Name [1] 302635 0
Address [1] 302635 0
Country [1] 302635 0

Ethics approval
Ethics application status
Ethics committee name [1] 303317 0
Western Sydney Local Health District Human Research Ethics Committee (WSLHD HREC)
Ethics committee address [1] 303317 0
Westmead Hospital, Corner Hawkesbury & Darcy Rd, Westmead 2145, Sydney, New South Wales.
Ethics committee country [1] 303317 0
Date submitted for ethics approval [1] 303317 0
Approval date [1] 303317 0
Ethics approval number [1] 303317 0

Brief summary
The purpose of the study is to determine whether there is increased post-operative throat pain associated with Moffett's solution nasal preparation when compared with Co-phenylcaine. We hypothesize that there will be an increased in post-operative throat pain in the Moffett's solution group.
Trial website
Trial related presentations / publications
Public notes
The study was approved by the Western Sydney Local Health District Human Research Ethics Committee (WSLHD HREC) as a low and negligible risk project (reference number: LNR/17/WMEAD/568). The WSLHD HREC is accredited by the New South Wales Ministry of Health to provide ethical and scientific review to conduct research within the NSW public health system. The study operates in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research and the CPMP/ ICH Note for guidance on Good Clinical Practice and the International guidelines for observational studies.

Principal investigator
Name 93250 0
Dr Dominic Ku
Address 93250 0
Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145, Sydney, New South Wales.
Country 93250 0
Phone 93250 0
+61 02 88905555
Fax 93250 0
Email 93250 0
Contact person for public queries
Name 93251 0
Dr Dominic Ku
Address 93251 0
Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145, Sydney, New South Wales.
Country 93251 0
Phone 93251 0
+61 02 88905555
Fax 93251 0
Email 93251 0
Contact person for scientific queries
Name 93252 0
Dr Dominic Ku
Address 93252 0
Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145, Sydney, New South Wales.
Country 93252 0
Phone 93252 0
+61 02 88905555
Fax 93252 0
Email 93252 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 2016 0
Informed consent form
Citation [1] 2016 0
Link [1] 2016 0
Email [1] 2016 0
Other [1] 2016 0
Type [2] 2047 0
Study protocol
Citation [2] 2047 0
Link [2] 2047 0
Email [2] 2047 0
Other [2] 2047 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Other publication details
Citation type [1] 2017 0
Citation/DOI/link/details [1] 2017 0
ASOHNS March 2019, Moffett’s solution in sinonasal surgery causes post-operative throat pain, which can be avoided using novel techniques.
Results – basic reporting
Results – plain English summary