Pharmacokinetics of oral diclofenac and acetaminophen in children after surgery.
BACKGROUND
Our aim was to study the pharmacokinetics and pain scores following administration of single oral doses of either diclofenac or high-dose acetaminophen (paracetamol).


METHODS
In the morning, the day after tonsillectomy, children 5-15 years of age were randomized in a double-blind manner to receive either diclofenac 1-2 mg.kg-1 (n=11) or acetaminophen 22.5 mg.kg-1 (n=10). Postoperative pain was assessed by self-report and blood samples were drawn every 30 min for 4 h after medication.


RESULTS
Large interindividual differences in maximum plasma diclofenac concentrations (Cmax) were found. Mean Cmax was 2.4+/-1.3 microg.ml-1 and mean tmax was 2+/-0.5 h. No significant reduction in pain score with diclofenac was seen at any of the assessments during the study period. Eight of 10 children achieved Cmax of acetaminophen within the 10-20 microg.ml-1 antipyretic range. Mean tabs was 0.7+/-0.3 h and mean Cmax and tmax were 12.7+/-3.8 microg ml-1 and 1.4+/-0.5 h, respectively. No significant reduction in pain score with acetaminophen was seen at any of the assessments during the study period.


CONCLUSIONS
The achieved concentrations of diclofenac and acetaminophen were not able to significantly reduce the children's pain score during the 5 h postingestion study period. Analgesic plasma acetaminophen concentrations may be higher than those required for antipyresis.
The Royal Danish School of Pharmacy, Department of Pharmaceutics, 2 Universitetsparken, DK-2100 Copenhagen, Denmark. jr@dfh.dk
J
J
Rømsing
D
D
Ostergaard
T
T
Senderovitz
D
D
Drozdziewicz
J
J
Sonne
G
G
Ravn
D000082:Acetaminophen / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000284:Administration, Oral; D000293:Adolescent; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002648:Child; D002675:Child, Preschool; D004008:Diclofenac / Q000008:administration & dosage / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010149:Postoperative Pain / Q000188:drug therapy*; D014068:Tonsillectomy
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D000082:Acetaminophen