None listed
Conditions
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.
Interventions
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
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.
Sponsors
Edwin Tamashiro
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
Indication for tonsillectomy or adenotonsillectomy Children between 4-10 years old Low anaesthesic risk (ASA 1, ASA 2)
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)
Outcome results
None listed