The use of diclofenac sodium (Voltaren) suppositories as an antipyretic in children with fever due to acute infections: a double-blind, between-patient, placebo-controlled study.

Abstract

In a placebo-controlled double-blind, between-patient trial the antipyretic effect of diclofenac sodium (voltaren) was studied in forty-three children ranging from 2-10 years of age. All patients were hospitalized because of acute illness associated with fever (38.5 degrees C-40.4 degrees C; mean 39.3 degrees C) due to viral or bacterial infections. The trial medication was given in the form of suppositories containing 25 mg of diclofenac sodium or as matching placebo to children aged from 2-5 years. The children aged from 6-10 years received a 50 mg diclofenac sodium suppository or placebo. Body temperature and pulse rate were measured at the time of administration and after 1/2, 1, 2, 4, and 6 hours. The results showed a return to normal temperature values after 2 hours in all patients receiving diclofenac sodium, whereas in the placebo group only minimal changes were observed. No unwanted effects were reported.