Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study

Arch Pediatr Adolesc Med. 2006 Feb;160(2):197-202. doi: 10.1001/archpedi.160.2.197.

Abstract

Objective: To compare the antipyretic benefit of acetaminophen or ibuprofen monotherapy with an alternating regimen of both drugs in young children aged 6 to 36 months.

Design: Randomized, double-blind, parallel-group trial.

Setting: Three primary pediatric community ambulatory centers in central Israel.

Participants: A total of 464 children aged 6 to 36 months with fever.

Intervention: Infants were assigned to receive either acetaminophen (12.5 mg/kg per dose every 6 hours) (n = 154) or ibuprofen (5 mg/kg per dose every 8 hours) (n = 155) or to receive alternating acetaminophen and ibuprofen (every 4 hours) (n = 155) for 3 days after a loading dose.

Main outcome measures: Temperature, stress score, amount of antipyretic received, total days that the infant or caregiver was absent from day care or work, respectively, at the 3-day time point, recurrence of fever, and number of emergency department visits.

Results: The group given the alternating regimen was characterized by a lower mean temperature, more rapid reduction of fever, receiving less antipyretic medication, less stress, and less absenteeism from day care as compared with the other groups; all of the differences were statistically significant (P< .001). None of the regimens were associated with a significantly higher number of emergency department visits (P = .65) or serious long-term complications (P = .66). The drug used for initial loading had no effect on outcome in any of the groups.

Conclusions: An alternating treatment regimen of acetaminophen (12.5 mg/kg per dose) and ibuprofen (5 mg/kg per dose) every 4 hours for 3 days, regardless of the initial loading medication, is more effective than monotherapy in lowering fever in infants and children.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Acetaminophen / administration & dosage*
  • Analgesics, Non-Narcotic / administration & dosage*
  • Child, Preschool
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fever / drug therapy*
  • Follow-Up Studies
  • Humans
  • Ibuprofen / administration & dosage*
  • Infant
  • Male

Substances

  • Analgesics, Non-Narcotic
  • Acetaminophen
  • Ibuprofen