Abstract | OBJECTIVE: 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: 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 degrees C vs 38.9 degrees C; difference, 0.7 degrees C; 95% confidence interval, -0.9 degrees C to -0.6 degrees C; P < .001), and this phenomenon was independent of the medication given. CONCLUSIONS:
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Authors | Teemu Strengell, Matti Uhari, Rita Tarkka, Johanna Uusimaa, Reija Alen, Pentti Lautala, Heikki Rantala |
Journal | Archives of pediatrics & adolescent medicine
(Arch Pediatr Adolesc Med)
Vol. 163
Issue 9
Pg. 799-804
(Sep 2009)
ISSN: 1538-3628 [Electronic] United States |
PMID | 19736332
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Placebos
- Suppositories
- Diclofenac
- Acetaminophen
- Ibuprofen
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Topics |
- Acetaminophen
(administration & dosage, therapeutic use)
- Administration, Oral
- Analysis of Variance
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, therapeutic use)
- Chi-Square Distribution
- Child, Preschool
- Diclofenac
(administration & dosage, therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Ibuprofen
(administration & dosage, therapeutic use)
- Infant
- Male
- Placebos
- Secondary Prevention
- Seizures, Febrile
(prevention & control)
- Suppositories
- Time Factors
- Treatment Outcome
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