Document Detail


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.
MedLine Citation:
PMID:  20380479     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Hannu Kokki; Merja Kokki
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Clinical drug investigation     Volume:  30     ISSN:  1173-2563     ISO Abbreviation:  Clin Drug Investig     Publication Date:  2010  
Date Detail:
Created Date:  2010-05-05     Completed Date:  2010-07-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9504817     Medline TA:  Clin Drug Investig     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  375-86     Citation Subset:  IM    
Affiliation:
Department of Anesthesiology and Intensive Care, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland. hannu.kokki@kuh.fi
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MeSH Terms
Descriptor/Qualifier:
Acetaminophen / 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:
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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