Ketoprofen versus Paracetamol (Acetaminophen) or Ibuprofen in the Management of Fever
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ORIGINAL RESEARCH ARTICLE
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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 Hannu Kokki and Merja Kokki Department of Anesthesiology and Intensive Care, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland
Abstract
Background: Fever is a common symptom in children and one of the major concerns of parents of younger and preschool-age children. Objective: To compare the efficacy and safety of ketoprofen with that of paracetamol (acetaminophen) and ibuprofen in the treatment of febrile conditions in children. Methods: 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 ‡38.8C or rectal temperature of ‡39C 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). Results: All three treatments provided similar mean maximum decreases of 1.4–1.5C 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. Conclusion: 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.
Kokki & Kokki
376
Background Fever is a common acute-phase physiological response during illnesses. Young children may have up to four to five acute infections annually and thus feverish episodes are frequent during childhood.[1] Fever is one of the main health concerns of preschool-age children’s parents, and therefore they consult healthcare professionals on average 3–4 times a year for advice about this concern.[2,3] Most fevers are caused by self-limiting conditions, and low levels of fever need not necessarily be treated. However, if the fever causes distress to a child’s well-being, with poor appetite and sleeping disturbance making the child irritable, use of antipyretics is indicated. Also, in those children with compromised physiological reserves, an active approach should be taken to prevent the potential harms a high metabolic rate associated with elevated body temperature may cause. Moreover, the views and wishes of children and parents should be taken into consideration when deciding on the use of antipyretic treatment.[4] Paracetamol (acetaminophen) has been a standard in the management of fever be
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