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


METHODS
Randomized, double-blind, parallel-group trial.


METHODS
Three primary pediatric community ambulatory centers in central Israel.


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


METHODS
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.


METHODS
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.
Sarrell
E Michael
EM
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. sarrell@netvision.net.il
Wielunsky
Eliahu
E
Cohen
Herman Avner
HA
D000082:Acetaminophen / Q000008:administration & dosage*; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000188:drug therapy*; D005500:Follow-Up Studies; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D007223:Infant; D008297:Male
D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen; D007052:Ibuprofen