RESUMO
OBJECTIVE: To evaluate the efficacy and safety of celecoxib for pain management in post-tonsillectomy adult patients. DESIGN: A randomised, double-blind, placebo-controlled, phase 3 clinical trial was conducted in an adult population (aged 18-55 years), with a parallel group design using an allocation ratio of 1:1. METHODS: Eighty patients underwent elective tonsillectomy or adenotonsillectomy, operated on by one surgeon. They were discharged home with randomly assigned celecoxib or placebo, together with regular post-tonsillectomy medications (paracetamol and Endone). Pain scores were measured from post-operative days 1 to 10. All patients were assessed on post-operative days 5, 12 and 28. RESULTS: There were no statistically significant differences in the daily or overall pain scores, the total intake of Endone, or the time taken to achieve freedom from pain after tonsillectomy between the study arms (n = 40 each arm). The celecoxib-treated group experienced significantly more vomiting (celecoxib vs placebo p < 0.001 (Mann-Whitney test), confidence interval = 0.57 to 0.76). CONCLUSION: Celecoxib usage was associated with significantly more vomiting and did not reduce narcotic analgesia requirement post-tonsillectomy.
