Double-blind, placebo-controlled analgesic study of ibuprofen or rofecoxib in combination with paracetamol for tonsillectomy in children

Br J Anaesth. 2002 Jan;88(1):72-7. doi: 10.1093/bja/88.1.72.


Background: The analgesics used for paediatric tonsillectomy may be associated with side-effects such as sedation, respiratory depression and vomiting (opioids) or increased bleeding [non-steroidal anti-inflammatory drugs (NSAIDs)]. In our institution, we employ a combination of paracetamol, NSAID and opioid, although there is no published evidence of analgesic benefit from adding NSAIDs to paracetamol in children.

Methods: This randomized, double-blinded clinical study examined the analgesic effectiveness of combining paracetamol (20 mg kg(-1)) with rofecoxib (0.625 mg kg(-1)), ibuprofen (5 mg kg(-1)) or placebo as premedication for (adeno)tonsillectomy (n=98) in children aged 3-15 yr. Intravenous fentanyl 1-2 microg kg(-1) was given intraoperatively. Regular oral paracetamol (15 mg kg(-1), 4 hourly) was given after operation and could be supplemented on request from the child with oral ibuprofen 5 mg kg(-1) or oral codeine 1 mg kg(-1). The primary outcome variable was need for early supplementary analgesia (within 2 h after surgery).

Results: The addition of ibuprofen to paracetamol reduced the need for early analgesia from 72% to 38% of children (difference 34%; 95% confidence interval 4-64%). The addition of rofecoxib to paracetamol did not significantly alter the need for early analgesia (68 vs 72%). Pain scores were higher in those children who required early analgesia. There were no differences between the groups in operative blood loss or complications, total 24-h analgesic consumption, pain scores at 4 and 8 h, vomiting or antiemetic use.

Conclusion: This study provides evidence to support the combination of ibuprofen (but not rofecoxib) with paracetamol for perioperative analgesia in children.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acetaminophen / therapeutic use
  • Adenoidectomy
  • Adolescent
  • Analgesics, Non-Narcotic / therapeutic use*
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Blood Loss, Surgical
  • Child
  • Child, Preschool
  • Cyclooxygenase Inhibitors / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Ibuprofen / therapeutic use*
  • Infant
  • Lactones / therapeutic use*
  • Male
  • Pain, Postoperative / prevention & control*
  • Premedication / methods*
  • Sulfones
  • Tonsillectomy*


  • Analgesics, Non-Narcotic
  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase Inhibitors
  • Lactones
  • Sulfones
  • rofecoxib
  • Acetaminophen
  • Ibuprofen