Antipyretic efficacy of tiaprofenic acid in febrile children.
In children, tiaprofenic acid (TA), a non steroidal antiinflammatory drug, propionic-acid derivative, has been proven effective in the treatment of symptoms of tonsillitis and pharyngitis but not yet in the symptomatic treatment of fever. This double-blind, parallel group, placebo (Pl) controlled study was designed in order to demonstrate the antipyretic activity of TA. The co-prescription of other antipyretic medications in children may therefore be avoided. Two groups of children, 29 (TA group) and 26 (Pl group), were included and received either 4.2 +/- 0.5 mg/kg of TA given orally in a single dose or a Pl match. Rectal temperature was recorded just before and 1, 2, 4 and 6 hours after dosing. The maximum temperature decrease was significantly greater in the TA group (-1.3 degrees C +/- 0.7 degree C) than in the Pl group (-0.4 degree C +/- 0.8 degree C). The percentage of children who needed a rescue treatment during the study was 35% (10/29) and 62% (16/26) in the TA and Pl group, respectively. The rescue treatment was composed of a single oral acetaminophen dose in case of fever above 39.5 degrees C or if the temperature decrease was not at least equal to 0.6 degree C four hours after dosing. No major side effect was reported by the parents during the study period. In conclusion, TA at a single mean 4.2 mg/kg oral dose, is an effective antipyretic drug in febrile children. The duration of the antipyretic effect was estimated as at least four hours.
Département de Pharmacologie Clinique Périnatale et Pédiatrique, Hôpital Saint-Vincent de Paul, Paris, France.
F
F
Vauzelle-Kervroëdan
Y
Y
Revzani
G
G
Pons
L
L
Consten
A
A
Pariente-Khayat
P
P
d'Athis
G
G
Olive
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001831:Body Temperature / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011422:Propionates / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011422:Propionates; C021270:tiaprofenic acid