Amoxicillin,Ibuprofen,or Prednisolone Does Not Modify Post-tonsillectomy Pain in Children: A Randomized Controlled Trial

Abstract

Objectives:

Evaluate the effect of amoxicillin, ibuprofen, or prednisolone on post-tonsillectomy pain in children.

Methods:

225 children between 6-10 years-old undergoing cold knife adenotonsillectomy/tonsillectomy were included in the study. Pain was monitored in the first seven days after surgery by the parent’s (“Parents’ Post-Operative Pain” -PPPM) and child’s assignment (“Revised-Facial Pain Scale” -R-FPS). Pain was also indirectly analyzed by the number of analgesic administration and return to solid food intake. 45 children were randomized into 5 distinct groups, with the respective number of patients analyzed after losses and exclusions: 1) control n = 42; 2) amoxicillin 50mg/kg/day, n = 31; 3) oral prednisolone 0.5mg/kd/day, n = 30; 4) ibuprofen 5mg/kg/dose tid, n = 32; 5) amoxicillin plus prednisolone, n = 37. All groups received oral analgesics (dypirone and acetaminophen) to use as required. PPPM was analyzed by a linear regression model with mixed effects with Tukey post-test for multiple comparisons (SAS 9.0). R-FPS and analgesic intake were analyzed by Kruskal-Wallis. Return to solid intake was analyzed by Wilcoxon test, considering significant when P < 0.05.

Results:

Multiple comparisons demonstrated that the evolution of pain, matched day-per-day among the different groups, was not statistically different either by PPPM or R-FPS (P > 0.05). The number of analgesic intake was also similar in all groups (P = 0.10) as well as the return to solid food intake (P = 0.41). Also, all groups presented a similar standard of clinical improvement in intervals of two days (P < 0.01).

Conclusions:

Our data demonstrate that the addition of amoxicillin, ibuprofen, or prednisolone to simple analgesic prescription does not modify post-tonsillectomy pain in children.