title: Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies.
abstract: Two blinded single-dose studies randomized children 6 months to 11 years old with fever to receive ibuprofen (IBU) pediatric suspension 7.5 mg/kg or acetaminophen (APAP) suspension 10 to 15 mg/kg. The primary efficacy parameter was time-weighted sum of temperature differences (TWSTD) from baseline through 8 hours for each study. Secondary end points included TWSTD from baseline through 6 hours, time to onset and duration of temperature control, and proportion with temperature control. Studies were pooled for post hoc analyses of efficacy and adverse event end points. The primary efficacy parameter significantly favored IBU over APAP in study 1 and the pooled analysis (both P < .001), but was not significant in study 2. Onset of temperature control significantly favored IBU in study 2 ( P = .007). Individual and pooled secondary efficacy outcomes supported significant advantages ( P < .05) of IBU over APAP. IBU pediatric suspension provided greater temperature reduction versus acetaminophen in febrile children, with a comparable safety profile.
authors.affiliation: 1 Pfizer Consumer Healthcare, Madison, NJ, USA.
authors.forename: Shyamalie
authors.initials: S
authors.lastname: Jayawardena
authors.affiliation: 1 Pfizer Consumer Healthcare, Madison, NJ, USA.
authors.forename: David
authors.initials: D
authors.lastname: Kellstein
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D058633:Antipyretics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D058633:Antipyretics; D000082:Acetaminophen; D007052:Ibuprofen
keywords: acetaminophen; fever; ibuprofen; pediatrics; randomized controlled trial