| Ketoprofen versus paracetamol (acetaminophen) or ibuprofen in the management of fever: results of two randomized, double-blind, double-dummy, parallel-group, repeated-dose, multicentre, phase III studies in children. | |
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MedLine Citation:
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PMID: 20380479 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Fever is a common symptom in children and one of the major concerns of parents of younger and preschool-age children. To compare the efficacy and safety of ketoprofen with that of paracetamol (acetaminophen) and ibuprofen in the treatment of febrile conditions in children. Two prospective, randomized, double-blind, double-dummy, repeated-dose, multicentre, phase III studies with two parallel groups in each study were conducted in primary-care outpatient clinics. Children aged 6 months to 6 years presenting with a febrile condition and an oral body temperature of > or =38.8 degrees C or rectal temperature of > or =39 degrees C were eligible for inclusion. Patients were randomized to receive either ketoprofen syrup 0.5 mg/kg, ibuprofen suspension 5 mg/kg or paracetamol suspension 15 mg/kg every 6 hours by the oral route. The primary outcome measure was the change in temperature at 3 hours (H3), compared with baseline (H0). All three treatments provided similar mean maximum decreases of 1.4-1.5 degrees C in body temperature at H3 compared with H0. Use of ketoprofen was not associated with any increased risk of adverse events compared with the two reference compounds. Ketoprofen 0.5 mg/kg appeared to be equivalent to the standard antipyretic doses of the reference products ibuprofen 5 mg/kg and paracetamol 15 mg/kg. Ketoprofen at the 0.5 mg/kg dose should be an effective and safe option for symptomatic management of fever in children. |
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Authors:
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Hannu Kokki; Merja Kokki |
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Publication Detail:
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Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Clinical drug investigation Volume: 30 ISSN: 1173-2563 ISO Abbreviation: Clin Drug Investig Publication Date: 2010 |
Date Detail:
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Created Date: 2010-05-05 Completed Date: 2010-07-22 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9504817 Medline TA: Clin Drug Investig Country: New Zealand |
Other Details:
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Languages: eng Pagination: 375-86 Citation Subset: IM |
Affiliation:
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Department of Anesthesiology and Intensive Care, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland. hannu.kokki@kuh.fi |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acetaminophen
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administration & dosage,
adverse effects,
therapeutic use* Administration, Oral Analgesics, Non-Narcotic / administration & dosage, adverse effects, therapeutic use Anti-Inflammatory Agents, Non-Steroidal / administration & dosage, adverse effects, therapeutic use Child Child, Preschool Double-Blind Method Female Fever / drug therapy* Humans Ibuprofen / administration & dosage, adverse effects, therapeutic use* Infant Ketoprofen / administration & dosage, adverse effects, therapeutic use* Male Prospective Studies Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Analgesics, Non-Narcotic; 0/Anti-Inflammatory Agents, Non-Steroidal; 103-90-2/Acetaminophen; 15687-27-1/Ibuprofen; 22071-15-4/Ketoprofen |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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