Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000772145
Ethics application status
Approved
Date submitted
7/05/2019
Date registered
24/05/2019
Date last updated
24/05/2019
Date data sharing statement initially provided
24/05/2019
Date results information initially provided
24/05/2019
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
MoCo
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of previous sinonasal surgery were excluded from the study.

Study design
Purpose of the study
Treatment
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
Phase
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2018
Date of last participant enrolment
Anticipated
Actual
1/04/2019
Date of last data collection
Anticipated
Actual
2/04/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
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
Hospital
Name [1] 302707 0
Department of otolaryngology, Westmead Hospital
Country [1] 302707 0
Australia
Primary sponsor type
Hospital
Name
Department of otolaryngology, Westmead Hospital
Address
Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145 Sydney, New South Wales.
Country
Australia
Secondary sponsor category [1] 302635 0
None
Name [1] 302635 0
Address [1] 302635 0
Country [1] 302635 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 303317 0
Approval date [1] 303317 0
23/03/2018
Ethics approval number [1] 303317 0
LNR/17/WMEAD/568

Summary
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.

Contacts
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
Australia
Phone 93250 0
+61 02 88905555
Fax 93250 0
Email 93250 0
drdominicku@gmail.com
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
Australia
Phone 93251 0
+61 02 88905555
Fax 93251 0
Email 93251 0
drdominicku@gmail.com
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
Australia
Phone 93252 0
+61 02 88905555
Fax 93252 0
Email 93252 0
drdominicku@gmail.com

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2016Informed consent form    377548-(Uploaded-07-05-2019-11-08-35)-Study-related document.doc
2047Study protocol    377548-(Uploaded-10-05-2019-09-28-58)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIMoffett’s Solution Causes Significantly Greater Postoperative Throat Pain Compared to Cophenylcaine in Sinonasal Surgery2019https://doi.org/10.1155/2019/3738647
N.B. These documents automatically identified may not have been verified by the study sponsor.