Analgesic efficacy of rectal versus oral acetaminophen in children after major craniofacial surgery

Clin Pharmacol Ther. 2001 Jul;70(1):82-90. doi: 10.1067/mcp.2001.116794.


Background: Analgesic acetaminophen (INN, paracetamol) plasma concentrations after major surgery in neonates and infants have not yet been established in the literature. We therefore conducted a study in our intensive care unit.

Methods: Forty children, mean (standard deviation) age, 10.3 (2.3) months, received 20 mg/kg acetaminophen either orally (n = 20) or rectally (n = 20) every 6 hours after a rectal loading dose (40 mg/kg) during elective craniofacial correction. Blood samples were taken 1 hour before and 2 hours after administration of acetaminophen maintenance doses; pain scores were obtained every 3 hours.

Results: Acetaminophen plasma concentrations were higher in patients receiving rectal acetaminophen (mean area under the concentration-time curve [AUC], 171.2 mg x h/L) than in patients receiving oral acetaminophen (mean AUC, 111.9 mg x h/L). Pain scores were higher in patients receiving oral acetaminophen. However, after exclusion of the patients who vomited from the group receiving oral acetaminophen, acetaminophen plasma concentrations and pain scores did not differ between the groups. There was no relation between acetaminophen plasma concentrations and pain scores. Although 9 of all 40 patients (22.5%) did not reach the expected analgesic acetaminophen plasma concentrations of 10- to 20 mg/L, <7.5% of the visual analog scale pain scores exceeded 4 cm, which was considered as a cutoff point.

Conclusion: These are the first data showing that the analgesic acetaminophen plasma concentration after major surgery in this age group does not always reach the 10 to 20 mg/L level. These data also show that, after a rectal loading dose of 40 mg/kg has been given during surgery, the best way of administering acetaminophen after craniofacial surgery is the rectal route.

MeSH terms

  • Acetaminophen / administration & dosage*
  • Acetaminophen / blood
  • Acetaminophen / pharmacology*
  • Administration, Oral
  • Administration, Rectal
  • Analgesics, Non-Narcotic / administration & dosage*
  • Analgesics, Non-Narcotic / blood
  • Analgesics, Non-Narcotic / pharmacology*
  • Area Under Curve
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Facial Pain / drug therapy*
  • Facial Pain / etiology
  • Facial Pain / prevention & control
  • Female
  • Humans
  • Infant
  • Male
  • Pain, Postoperative / drug therapy*
  • Pain, Postoperative / etiology
  • Pain, Postoperative / prevention & control


  • Analgesics, Non-Narcotic
  • Acetaminophen