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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?
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Scientific title
A comparison of post-operative throat pain in patients prepared with Moffett's solution versus Co-phenylcaine in sinonasal surgery.
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Secondary ID [1]
298172
0
Nil known.
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Universal Trial Number (UTN)
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Trial acronym
MoCo
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic rhinosinusitis
312735
0
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nasal obstruction
312736
0
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post-operative pain
312738
0
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Condition category
Condition code
Surgery
311234
311234
0
0
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Other surgery
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Respiratory
311274
311274
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314424
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
319991
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Post-operative throat pain measured by 10 point VAS.
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Assessment method [1]
319991
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Timepoint [1]
319991
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1st day post-operatively
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Secondary outcome [1]
370117
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post-operative throat pain measured by 10 point VAS.
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Assessment method [1]
370117
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Timepoint [1]
370117
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second day post-operatively
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Eligibility
Key inclusion criteria
Patients undergoing routine sinonasal surgery (septoplasty, turbinate surgery, functional endoscopic sinus surgery) requiring nasal preparation.
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Minimum age
15
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with a history of previous sinonasal surgery were excluded from the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/05/2018
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Date of last participant enrolment
Anticipated
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Actual
1/04/2019
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Date of last data collection
Anticipated
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Actual
2/04/2019
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
13699
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Westmead Hospital - Westmead
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Recruitment hospital [2]
13700
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Nepean Hospital - Kingswood
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Recruitment postcode(s) [1]
26391
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2145 - Westmead
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Recruitment postcode(s) [2]
26392
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2747 - Kingswood
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Funding & Sponsors
Funding source category [1]
302707
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Hospital
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Name [1]
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Department of otolaryngology, Westmead Hospital
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Address [1]
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Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145 Sydney, New South Wales.
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Country [1]
302707
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Australia
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Primary sponsor type
Hospital
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Name
Department of otolaryngology, Westmead Hospital
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Address
Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145 Sydney, New South Wales.
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Country
Australia
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Secondary sponsor category [1]
302635
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None
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Name [1]
302635
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Address [1]
302635
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Country [1]
302635
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303317
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Western Sydney Local Health District Human Research Ethics Committee (WSLHD HREC)
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Ethics committee address [1]
303317
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Westmead Hospital, Corner Hawkesbury & Darcy Rd, Westmead 2145, Sydney, New South Wales.
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Ethics committee country [1]
303317
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Australia
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Date submitted for ethics approval [1]
303317
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Approval date [1]
303317
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23/03/2018
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Ethics approval number [1]
303317
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LNR/17/WMEAD/568
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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.
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Trial website
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Trial related presentations / publications
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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.
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Contacts
Principal investigator
Name
93250
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Dr Dominic Ku
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Address
93250
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Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145, Sydney, New South Wales.
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Country
93250
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Australia
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Phone
93250
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+61 02 88905555
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Fax
93250
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Email
93250
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[email protected]
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Contact person for public queries
Name
93251
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Dr Dominic Ku
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Address
93251
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Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145, Sydney, New South Wales.
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Country
93251
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Australia
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Phone
93251
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+61 02 88905555
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Fax
93251
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Email
93251
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[email protected]
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Contact person for scientific queries
Name
93252
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Dr Dominic Ku
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Address
93252
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Corner of Hawkesbury and Darcy Road, Westmead Hospital, Westmead 2145, Sydney, New South Wales.
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Country
93252
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Australia
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Phone
93252
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+61 02 88905555
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Fax
93252
0
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Email
93252
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
2016
Informed consent form
377548-(Uploaded-07-05-2019-11-08-35)-Study-related document.doc
2047
Study 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
Source
Title
Year of Publication
DOI
Dimensions AI
Moffett’s Solution Causes Significantly Greater Postoperative Throat Pain Compared to Cophenylcaine in Sinonasal Surgery
2019
https://doi.org/10.1155/2019/3738647
N.B. These documents automatically identified may not have been verified by the study sponsor.
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