title: Acetaminophen controlled-release sprinkles versus acetaminophen immediate-release elixir in febrile children.
abstract: Current acetaminophen (APAP) formulations approved for antipyretic use in children require up to five doses/day, which compromise compliance and risk breakthrough fever over 4 hours after dosing. A total of 112 evaluable febrile children received oral APAP-equivalent doses of either one dose of APAP controlled release (CR) as sprinkles on applesauce or one dose q 4 hours x 2 of APAP immediate-release (IR) elixir in an 8-hour, double-blind, double-dummy, randomized, multicenter study. Prior or concurrent antibiotic use did not significantly affect either the magnitude or the pattern of temperature reduction during the 8-hour observation period. Significantly greater aural temperature reductions were found with APAP-CR than with APAP-IR at 4 and 5 hours. However, the 8-hour AUCs of temperature reduction were not significantly different between treatments. Pharmacokinetic/pharmacodynamic modeling of APAP was performed in 8 patients with values in both treatments similar to previous results, except for expected differences in AUC0-infinity. Similar 8-hour temperature reduction for APAP-CR (one dose) and APAP-IR (two doses) demonstrates the efficacy of APAP-CR as an antipyretic in children 2 to 11 years of age. A decrease in the number of APAP daily doses and the prolonged antipyretic effect of APAP-CR may assist those who care for febrile children at home.
authors.affiliation: Department of Pediatrics, Louisiana State University Medical Center, Shreveport 71130-3932, USA.
authors.forename: J T
authors.initials: JT
authors.lastname: Wilson
authors.forename: R
authors.initials: R
authors.lastname: Helms
authors.forename: B D
authors.initials: BD
authors.lastname: Pickering
authors.forename: L
authors.initials: L
authors.lastname: Donahue
authors.forename: R D
authors.initials: RD
authors.lastname: Brown
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001007:Anxiety / Q000139:chemically induced; D019540:Area Under Curve; D001831:Body Temperature / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D003221:Confusion / Q000139:chemically induced; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D008297:Male; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D018712:Analgesics, Non-Narcotic; D003692:Delayed-Action Preparations; D000082:Acetaminophen