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Trial registered on ANZCTR


Registration number
ACTRN12610001084077
Ethics application status
Approved
Date submitted
8/12/2010
Date registered
10/12/2010
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of different medications for the control of pain after tonsils and adenoid surgery.
Scientific title
Comparative, prospective, and randomized study of tonsillectomy/adenotonsillectomy post-operative pain control in children.
Secondary ID [1] 253270 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain control after tonsillectomy/adenotonsillectomy 258797 0
Condition category
Condition code
Oral and Gastrointestinal 258928 258928 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
During the 7 days after tonsillectomy/adenotonsillectomy, children between 4-10 years will receive either analgesic alone as necessary (dipyrone - 20mg/kg/dose - or acetaminofen - 15mg/kg/dose, up to 4 times a day, oral drops) or analgesics combined with amoxicilin (50mg/kg/day, 3 times a day for 7 days, oral suspension), prednisolone (0.5mg/kg/day once a day for 7 days, oral solution), ibuprofen (15mg/kg/day, divided in 3 times a day for 7 days, oral drops) or amoxicilin+prednisolone for 7 days.
Intervention code [1] 257714 0
Treatment: Drugs
Comparator / control treatment
Children will receive analgesics (dipyrone -20mg/kg/dose- or acetaminofen- 15mg/kg/dose) as necessary, up to 4 times a day each. Dipyrone will prefferentially be administered, unless there is history of allergy to dipyrone or there is need of pain control between the intervals of dipyrone use - in these situations, acetaminofen will be used.
Control group
Active

Outcomes
Primary outcome [1] 259801 0
Post-operative pain control measured by a clinical questionare that will be fill up by the parents or responsibles (PPP-parents's post-operative pain measure) and by The Faces Pain Scale-Revised filled up by the patient.
Timepoint [1] 259801 0
7 days after surgery
Secondary outcome [1] 268601 0
Evaluation of side effects with different therapies (diarrhea, abdominal pain, skin rash, bleeding)
Timepoint [1] 268601 0
7 days after surgery

Eligibility
Key inclusion criteria
Indication for tonsillectomy or adenotonsillectomy
Children between 4-10 years old
Low anaesthesic risk (ASA 1, ASA 2)
Minimum age
4 Years
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Child neuropsycological impairment
Use of medications for chronic pain control
Use of antibiotics or anticoagulants
Perfomance of another concomitant surgery (frenulectomy, ventilation tube insertion, etc)
Allergy to any medication proposed in this study (amoxicilin, prednisolone, ibuprofen)

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)
Allocation will be concealed by contacting the holder of the allocation (principal investigator) by phone, who will be off-site, at the day of the surgery
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computed sequence randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3078 0
Brazil
State/province [1] 3078 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 258192 0
University
Name [1] 258192 0
Faculty of Medicine of Ribeirao Preto - University of Sao Paulo
Address [1] 258192 0
Avenida dos Bandeirantes, 3900
Monte Alegre
Ribeirao Preto-SP
CEP 14049-900
Country [1] 258192 0
Brazil
Funding source category [2] 289048 0
Charities/Societies/Foundations
Name [2] 289048 0
FAPESP - Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Address [2] 289048 0
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 Sao Paulo/SP - Brasil
Country [2] 289048 0
Brazil
Primary sponsor type
Individual
Name
Edwin Tamashiro
Address
Av dos Bandeirantes, 3900
Monte Alegre
Ribeirao Preto-SP
CEP 14049-900
Country
Brazil
Secondary sponsor category [1] 257368 0
None
Name [1] 257368 0
Address [1] 257368 0
Country [1] 257368 0
Other collaborator category [1] 251721 0
Individual
Name [1] 251721 0
Carolina Brotto de Azevedo
Address [1] 251721 0
Av dos Bandeirantes, 3900
Monte Alegre
Ribeirao Preto-SP
CEP 14049-900
Country [1] 251721 0
Brazil
Other collaborator category [2] 251722 0
Individual
Name [2] 251722 0
Danielle Leite Cunha
Address [2] 251722 0
Rua Antonio Deloiagono, 96 ap 41
Vila Ana Maria
Ribeirao Preto-SP
CEP 14026-210
Country [2] 251722 0
Brazil
Other collaborator category [3] 277912 0
Individual
Name [3] 277912 0
Lucas Rodrigues Carenzi
Address [3] 277912 0
Av dos Bandeirantes, 3900 Monte Alegre
CEP 14049-900
Ribeirao Preto - SP
Country [3] 277912 0
Brazil
Other collaborator category [4] 277913 0
Individual
Name [4] 277913 0
Wilma Terezinha Anselmo-Lima
Address [4] 277913 0
Av dos Bandeirantes, 3900 Monte Alegre
Ribeirao Preto - SP
CEP 14049-900
Country [4] 277913 0
Brazil
Other collaborator category [5] 277914 0
Individual
Name [5] 277914 0
Daniel Salgado Kupper
Address [5] 277914 0
Av dos Bandeirantes, 3900 Monte Alegre
Ribeirao Preto - SP
CEP 14049-900
Country [5] 277914 0
Brazil
Other collaborator category [6] 277915 0
Individual
Name [6] 277915 0
Fabiana Cardoso Pereira Valera
Address [6] 277915 0
Av dos Bandeirantes, 3900 Monte Alegre
Ribeirao Preto - SP
CEP 14049-900
Country [6] 277915 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260169 0
Human Research Ethics Comittee of the Hospital of Clinics of the Faculty of Medicine of Ribeirao Preto -USP
Ethics committee address [1] 260169 0
Av dos Bandeirantes, 3900
Monte Alegre
Ribeirao Preto-SP
CEP 14049-900
Ethics committee country [1] 260169 0
Brazil
Date submitted for ethics approval [1] 260169 0
Approval date [1] 260169 0
04/10/2010
Ethics approval number [1] 260169 0
9838/2010

Summary
Brief summary
Tonsillectomy and Adenotonsillectomy are the main surgeries performed in children worlwide. However, there is no consensus on how is the best way to manage pain after surgery in these cases. In this study, our primary goal will be to investigate if the additional use of antibiotics (amoxicilin), non-esteroidal antiinflammatory (ibuprofen) or corticosteroid (prednisolone) can change the history of pain that follows these surgeries. Additionally, we will also investigate if the use of these drugs in the post-operative period leads to adverse effects. Finally, we will balance the risk/benefit use of these drugs in the post-operative time of tonsillectomy/adenotonsillectomy in children.
Trial website
Trial related presentations / publications
Azevedo CB, Carenzi LR, Queiroz DLC, Anselmo-Lima WT, Valera FC, Tamashiro E. Clinical utility of PPPM and FPS-R to quantify post-tonsillectomy pain in children. Int J Pediatr Otorhinolaryngol. 2014 Feb;78(2):296-9. doi: 10.1016/j.ijporl.2013.11.027.27/11/2013
Public notes

Contacts
Principal investigator
Name 31994 0
A/Prof Edwin Tamashiro
Address 31994 0
Ribeirao Preto School of Medicine
University of Sao Paulo
Av dos Bandeirantes, 3900 Monte Alegre
Ribeirao Preto - SP - Brazil
CEP 14049-900
Country 31994 0
Brazil
Phone 31994 0
55-16-36022863
Fax 31994 0
Email 31994 0
edwintamashiro@yahoo.com.br
Contact person for public queries
Name 15241 0
A/Prof Edwin Tamashiro
Address 15241 0
Av dos Bandeirantes, 3900
Monte Alegre
Ribeirao Preto-SP
CEP 14049-900
Country 15241 0
Brazil
Phone 15241 0
55-16-3602-2863
Fax 15241 0
Email 15241 0
edwin@fmrp.usp.br
Contact person for scientific queries
Name 6169 0
A/Prof Edwin Tamashiro
Address 6169 0
Av dos Bandeirantes, 3900
Monte Alegre
Ribeirao Preto-SP
CEP 14049-900
Country 6169 0
Brazil
Phone 6169 0
55-16-3602-2863
Fax 6169 0
Email 6169 0
edwin@fmrp.usp.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary