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Previous Volume 329:79-84 July 8, 1993 Number 2 Next

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ABSTRACT

Background Phenobarbital, once widely prescribed to prevent febrile seizures, is now in disfavor because of its side effects and lack of efficacy. Diazepam, administered only during episodes of fever, may be a safe, effective agent to prevent the recurrence of febrile seizures.

Methods We conducted a randomized, double-blind, placebo-controlled trial among 406 children (mean age, 24 months) who had at least one febrile seizure. Diazepam (0.33 mg per kilogram of body weight) or placebo was administered orally every eight hours during all febrile illnesses.

Results During a mean follow-up of 1.9 years (a period during which 90 percent of febrile seizures recur), our intention-to-treat analysis showed a reduction of 44 percent in the risk of febrile seizures per person-year with diazepam (relative risk = 0.56; 95 percent confidence interval, 0.38 to 0.81; P = 0.002). A survival analysis of the length of time to the first recurrent febrile seizure did not show a significant difference between the treatment groups (P = 0.064 by the log-rank test), but after adjustment for covariates, diazepam was found to have a benefit (P = 0.027 by Cox regression analysis). An analysis restricted to children who had seizures while actually receiving the study medication (7 in the diazepam group and 29 in the placebo group) showed an 82 percent reduction in the risk of febrile seizures with diazepam (relative risk = 0.18; 95 percent confidence interval, 0.09 to 0.37; P<0.001). Of the 153 children who took at least one dose of diazepam, 39 percent had ataxia, lethargy, or irritability or at least one other moderate side effect that was reversed after a reduction in the dose. There were no severe side effects.

Conclusions Oral diazepam, given only when fever is present, is safe and reduces the risk of recurrent febrile seizures.

Source Information

From the Departments of Pediatrics and Neurology, Division of Pediatric Neurology, Tufts University School of Medicine (N.P.R., J.L., P.L.G., N.B.G., E.M.K.), and the Department of Epidemiology and Biostatistics, Boston University School of Public Health (T.C., C.V.B., M.R.W.), both in Boston.

Address reprint requests to Dr. Rosman at the Division of Pediatric Neurology, Floating Hospital for Children, New England Medical Center, 750 Washington St., Box 330, Boston, MA 02111.

Full Text of this Article

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Diazepam to Prevent Febrile Seizures
Berg A. T., Leiner S., Berg A. T., Shetty T., Camfield P., Camfield C., Rosman N. P., Colton T., Labazzo J.
Extract | Full Text  
N Engl J Med 1993; 329:2033-2035, Dec 30, 1993. Correspondence

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