Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000635268
Ethics application status
Not yet submitted
Date submitted
23/07/2009
Date registered
29/07/2009
Date last updated
29/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of a gel dressing on the tonsillectomy fossa to relieve post-tonsillectomy pain.
Scientific title
An investigation into post-operative pain in tonsillectomy patients with antibiotic-steroid gel applied to the tonsillectomy fossa compared to patients without the gel.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-tonsillectomy pain 237344 0
Condition category
Condition code
Surgery 239665 239665 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Antibiotic-steroid gel applied to tonsillectomy fossaeonce only during tonsillectomy.Exact formula of gel subject to patent application but has been disclosed to Belberry Ethics committee and TGA for approval.
Intervention code [1] 237005 0
Treatment: Drugs
Comparator / control treatment
Post-tonsillectomy patients without gel
Control group
Active

Outcomes
Primary outcome [1] 238439 0
To assess if gel reduces post-operative pain assessed by visual analogue scale(smiley face 1-10) commomly used to assess post-operative tonsillectomy pain.
Timepoint [1] 238439 0
5 days post-operatively.
Secondary outcome [1] 244941 0
Any increase in secondary haemorrhage as reported by patient(any bleeding from the tonsil fossa,how long the bleeding lasts and whether return to operating theatre is required).
Timepoint [1] 244941 0
Within 2 to 3 weeks of surgery

Eligibility
Key inclusion criteria
All patients having tonsillectomy above 5 years of age.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children less than 5 years old.

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)
Discussion pre-operatively with patient or parents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237388 0
Self funded/Unfunded
Name [1] 237388 0
Dr.Chris Dalton
Country [1] 237388 0
Australia
Primary sponsor type
Individual
Name
Dr.Chris Dalton
Address
Suite 18
Children's Hospital Medical Centre
Hainsworth St.
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 236888 0
None
Name [1] 236888 0
Address [1] 236888 0
Country [1] 236888 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239520 0
Ethics committee address [1] 239520 0
Ethics committee country [1] 239520 0
Date submitted for ethics approval [1] 239520 0
31/07/2009
Approval date [1] 239520 0
Ethics approval number [1] 239520 0

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

Contacts
Principal investigator
Name 29957 0
Address 29957 0
Country 29957 0
Phone 29957 0
Fax 29957 0
Email 29957 0
Contact person for public queries
Name 13204 0
Dr.Chris Dalton
Address 13204 0
Suite 18
Children's Hospital Medical Centre
Hainsworth St.
Westmead NSW 2145
Country 13204 0
Australia
Phone 13204 0
61 2 9633 2133
Fax 13204 0
61 2 9633 2515
Email 13204 0
[email protected]
Contact person for scientific queries
Name 4132 0
Dr.Chris Dalton
Address 4132 0
Suite 18
Children's Hospital Medical Centre
Hainsworth St.
Westmead NSW 2145
Country 4132 0
Australia
Phone 4132 0
61 2 9633 2133
Fax 4132 0
61 2 9633 2515
Email 4132 0
[email protected]

No information has been provided regarding IPD availability


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.