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 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.


CONCLUSIONS
This study provides evidence to support the combination of ibuprofen (but not rofecoxib) with paracetamol for perioperative analgesia in children.
Pickering
A E
AE
Sir Humphrey Davy Department of Anaesthesia, Bristol Royal Hospital for Children, UK.
Bridge
H S
HS
Nolan
J
J
Stoddart
P A
PA
D000082:Acetaminophen / Q000627:therapeutic use; D000233:Adenoidectomy; D000293:Adolescent; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D016063:Blood Loss, Surgical; D002648:Child; D002675:Child, Preschool; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D007223:Infant; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D010149:Postoperative Pain / Q000517:prevention & control*; D011292:Premedication / Q000379:methods*; D013450:Sulfones; D014068:Tonsillectomy
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D000082:Acetaminophen; D007052:Ibuprofen