An evaluation of the safety and efficacy of administering rofecoxib for postoperative pain management

Anesth Analg. 2003 Jul;97(1):35-8, table of contents. doi: 10.1213/01.ane.0000069507.93582.6e.


The goal of our study was to evaluate the analgesic efficacy and safety of administering rofecoxib (1 mg/kg), a cyclo-oxygenase (COX)-2 selective nonsteroidal antiinflammatory drug, before pediatric tonsillectomy. Sixty-six patients, aged 3-11 yr, scheduled to undergo tonsillectomy received either placebo or rofecoxib (1 mg/kg). There were no significant differences between the two study groups with respect to demographics and blood loss. We found that the pain scores were significantly lower in the rofecoxib group compared with the control group at 2 h (P < 0.05) and 24 h (P < 0.006). The incidence of nausea (P < 0.03) and vomiting (P < 0.004) at home was more frequent in the control group than in the rofecoxib group. We conclude that a single preoperative dose of rofecoxib resulted in less vomiting and lower 24-h pain scores in pediatric patients undergoing an elective tonsillectomy.

Implications: In children undergoing tonsillectomy, a single preoperative dose of rofecoxib decreases 2- and 24-h pain and decreases nausea and vomiting at home.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acetaminophen / therapeutic use
  • Analgesics, Non-Narcotic / therapeutic use
  • Analgesics, Opioid / therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Child
  • Child, Preschool
  • Codeine / therapeutic use
  • Female
  • Hemorrhage / chemically induced
  • Hemorrhage / epidemiology
  • Humans
  • Lactones / adverse effects*
  • Lactones / therapeutic use*
  • Male
  • Pain Measurement / drug effects
  • Pain, Postoperative / drug therapy*
  • Postoperative Complications / chemically induced
  • Postoperative Complications / epidemiology
  • Sulfones
  • Tonsillectomy


  • Analgesics, Non-Narcotic
  • Analgesics, Opioid
  • Anti-Inflammatory Agents, Non-Steroidal
  • Lactones
  • Sulfones
  • rofecoxib
  • Acetaminophen
  • Codeine