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Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies.
Clin Pediatr (Phila). 2017 Oct; 56(12):1120-1127.CPed

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+Show Affiliations

1 Pfizer Consumer Healthcare, Madison, NJ, USA.1 Pfizer Consumer Healthcare, Madison, NJ, USA.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27872357

Citation

Jayawardena, Shyamalie, and David Kellstein. "Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies." Clinical Pediatrics, vol. 56, no. 12, 2017, pp. 1120-1127.
Jayawardena S, Kellstein D. Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies. Clin Pediatr (Phila). 2017;56(12):1120-1127.
Jayawardena, S., & Kellstein, D. (2017). Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies. Clinical Pediatrics, 56(12), 1120-1127. https://doi.org/10.1177/0009922816678818
Jayawardena S, Kellstein D. Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies. Clin Pediatr (Phila). 2017;56(12):1120-1127. PubMed PMID: 27872357.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies. AU - Jayawardena,Shyamalie, AU - Kellstein,David, Y1 - 2016/11/20/ PY - 2016/11/23/pubmed PY - 2017/10/4/medline PY - 2016/11/23/entrez KW - acetaminophen KW - fever KW - ibuprofen KW - pediatrics KW - randomized controlled trial SP - 1120 EP - 1127 JF - Clinical pediatrics JO - Clin Pediatr (Phila) VL - 56 IS - 12 N2 - 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. SN - 1938-2707 UR - https://www.unboundmedicine.com/medline/citation/27872357/Antipyretic_Efficacy_and_Safety_of_Ibuprofen_Versus_Acetaminophen_Suspension_in_Febrile_Children:_Results_of_2_Randomized_Double_Blind_Single_Dose_Studies_ L2 - https://journals.sagepub.com/doi/10.1177/0009922816678818?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -