CompletedPhase 4ACTRN12610001084077

Comparison of different medications for the control of pain after tonsils and adenoid surgery.

Comparative, prospective, and randomized study of tonsillectomy/adenotonsillectomy post-operative pain control in children.


Sponsor

Edwin Tamashiro

Enrollment

100 participants

Start Date

Dec 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 10 Yearss

Inclusion Criteria3

  • Indication for tonsillectomy or adenotonsillectomy
  • Children between 4-10 years old
  • Low anaesthesic risk (ASA 1, ASA 2)

Exclusion Criteria5

  • 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)

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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

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.


Locations(1)

Sao Paulo, Brazil

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ACTRN12610001084077