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

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 μg 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.