Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001006033
Ethics application status
Approved
Date submitted
4/11/2009
Date registered
18/11/2010
Date last updated
18/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a short post-operative course of oral prednisone on post-operative morbidity following tonsillectomy in children.
Scientific title
Effect of a short post-operative course of oral prednisone versus placebo on post-operative morbidity following tonsillectomy in children.
Secondary ID [1] 253115 0
none
Universal Trial Number (UTN)
U1111-1112-2853
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recovery after tonsillectomy in children 252058 0
Condition category
Condition code
Surgery 252261 252261 0 0
Surgical techniques
Oral and Gastrointestinal 252378 252378 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
five day course of oral prednisolone post tonsillectomy (0.5mg/kg) once daily
Intervention code [1] 241455 0
Treatment: Drugs
Comparator / control treatment
placebo syrup. sugar syrup with identical flavour to prednisolone and same volume as equivalent paracetamol syrup. For five days post-operatively once daily
Control group
Placebo

Outcomes
Primary outcome [1] 253125 0
Visual analogue pain scale
Timepoint [1] 253125 0
2 hours post-operation
8 hours post-operation
days 1-8 post-operation once daily
Secondary outcome [1] 258002 0
nausea as presence or absence
Timepoint [1] 258002 0
2 hours post-operation
8 hours post-operation
days 1-8 post-operation once daily
Secondary outcome [2] 262220 0
vomiting - presence or absence of symtpom
Timepoint [2] 262220 0
2 hours post-operation
8 hours post-operation
days 1-8 post-operation once daily
Secondary outcome [3] 262221 0
return to normal function (eating, daily activities) - assessed as yes returned to normal function or no not returned to normal function.
Timepoint [3] 262221 0
2 hours post-operation
8 hours post-operation
days 1-8 post-operation once daily
Secondary outcome [4] 262222 0
change in behaviour. assessed with subjective questions
Timepoint [4] 262222 0
2 hours post-operation
8 hours post-operation
days 1-8 post-operation once daily

Eligibility
Key inclusion criteria
children undergoing tonsilectomy
age 2-16
anaesthetic rating using American Society of Anaesthesiologists standard rating 1 or 2
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
bleeding disorder
severe asthma

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using computer generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
198
Accrual to date
Final
Recruitment outside Australia
Country [1] 2296 0
New Zealand
State/province [1] 2296 0
Otago

Funding & Sponsors
Funding source category [1] 243926 0
Hospital
Name [1] 243926 0
Healthcare Otago Charitable Trust Grant
Country [1] 243926 0
New Zealand
Primary sponsor type
Hospital
Name
Healthcare Otago Charitable trust
Address
Dunedin Public Hospital
Great King Street
Dunedin 9001
New Zealand
Country
New Zealand
Secondary sponsor category [1] 251284 0
None
Name [1] 251284 0
Address [1] 251284 0
Country [1] 251284 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244038 0
Lower South Regional Ethics committee
Ethics committee address [1] 244038 0
Ethics committee country [1] 244038 0
New Zealand
Date submitted for ethics approval [1] 244038 0
Approval date [1] 244038 0
25/06/2009
Ethics approval number [1] 244038 0
LRS08/06/024

Summary
Brief summary
The purpose of the study is to see if a short course of a steroid mediation given post-operatively improves recovery after tonsillectomy in children. We hypothesize that oral prednisolone may be of benefit as an equivalent intravenous medication given at the time of tonsillectomy has been shown to be of benefit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30419 0
Address 30419 0
Country 30419 0
Phone 30419 0
Fax 30419 0
Email 30419 0
Contact person for public queries
Name 13666 0
Patrick Dawes
Address 13666 0
c/o Otolaryngology department
Dunedin Public Hospital
Gt King Street
Dunedin 9001
Country 13666 0
New Zealand
Phone 13666 0
006434740999
Fax 13666 0
Email 13666 0
patrick.dawes@healthotago.co.nz
Contact person for scientific queries
Name 4594 0
Patrick Dawes
Address 4594 0
c/o Otolaryngology department
Dunedin Public Hospital
Gt King Street
Dunedin 9001
Country 4594 0
New Zealand
Phone 4594 0
006434740999
Fax 4594 0
Email 4594 0
patrick.dawes@healthotago.co.nz

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.