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Randomized Controlled Trial

Teemu Strengell, MD; Matti Uhari, MD, PhD; Rita Tarkka, MD, PhD; Johanna Uusimaa, MD, PhD; Reija Alen, MD; Pentti Lautala, MD, PhD; Heikki Rantala, MD, PhD

Arch Pediatr Adolesc Med. 2009;163(9):799-804.

Objective  To evaluate the efficacy of different antipyretic agents and their highest recommended doses for preventing febrile seizures.

Design  Randomized, placebo-controlled, double-blind trial.

Setting  Five hospitals, each working as the only pediatric hospital in its region.

Participants  A total of 231 children who experienced their first febrile seizure between January 1, 1997, and December 31, 2003. The children were observed for 2 years.

Interventions  All febrile episodes during follow-up were treated first with either rectal diclofenac or placebo. After 8 hours, treatment was continued with oral ibuprofen, acetaminophen, or placebo.

Main Outcome Measure  Recurrence of febrile seizures.

Results  The children experienced 851 febrile episodes, and 89 of these included a febrile seizure. Febrile seizure recurrences occurred in 54 of the 231 children (23.4%). There were no significant differences between the groups in the main measure of effect, and the effect estimates were similar, as the rate was 23.4% (46 of 197) in those receiving antipyretic agents and 23.5% (8 of 34) in those receiving placebo (difference, 0.2; 95% confidence interval, –12.8 to 17.6; P = .99). Fever was significantly higher during the episodes with seizure than in those without seizure (39.7°C vs 38.9°C; difference, 0.7°C; 95% confidence interval, –0.9°C to –0.6°C; P < .001), and this phenomenon was independent of the medication given.

Conclusions  Antipyretic agents are ineffective for the prevention of recurrences of febrile seizures and for the lowering of body temperature in patients with a febrile episode that leads to a recurrent febrile seizure.

Trial Registration  clinicaltrials.gov Identifier: NCT00568217

Author Affiliations: Department of Pediatrics, University of Oulu, Oulu (Drs Strengell, Uhari, Tarkka, Uusimaa, and Rantala); Department of Pediatrics, Satakunta Central Hospital, Pori (Dr Tarkka); Division of Pediatric Neurology, Department of Pediatrics, Central Hospital of Central Finland, Jyväskylä (Dr Alen); Department of Pediatrics, Päijät-Häme Central Hospital, Lahti (Dr Lautala); and Department of Pediatrics, South Carelian Central Hospital, Lappeenranta (Dr Lautala), Finland.

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