For release: Wednesday, July 7, 1993
Oral diazepam (Valium), given at times of fever, safely reduces the risk of febrile seizure recurrence in infants and children, according to a study published in the July 8 issue of the New England Journal of Medicine * and funded by the National Institute of Neurological Disorders and Stroke (NINDS). Febrile seizures are fever-triggered convulsions that occur in approximately 3-4 percent of all children in the United States. Although they are generally harmless, their occurrence can cause alarm in the family.
The current study, coordinated by N. Paul Rosman, M.D., professor of pediatrics and neurology at Tufts University School of Medicine and director of pediatric neurology at Boston's Floating Hospital for Children, demonstrated a nearly 50 percent reduction in the risk of febrile seizure recurrence in over 400 children.
Until now, the most commonly prescribed treatment for febrile seizures has been phenobarbital taken once a day with many physicians reluctant to give daily medication to a child who has had one or a few febrile seizures. Furthermore, in a recent NINDS study, scientists found that a daily dose of phenobarbital was ineffective in preventing recurrence and that the drug can lower intellectual performance.
"We now have a medication that is effective when given during fevers and has no serious side effects for those children whose doctors feel it necessary to prescribe treatment," said NINDS Director Murray Goldstein, D.O., M.P.H.
Overall, about one-third of all children with febrile seizures have a recurrence. The rate jumps to one-half, however, in children under the age of 1. The risk of epilepsy (recurrent nonfebrile seizures) following febrile seizures is increased, but is still very small in most children with febrile seizures. It is substantially increased only in those children with multiple risk factors such as another neurological disorder, very long seizures, and a family history of epilepsy.
In this double-blind, randomized clinical trial, children received either diazepam or placebo from their caregiver, usually a parent, who was instructed to take the child's temperature at the first sign of illness. When the child's temperature was elevated, the caregiver gave diazepam every 8 hours until the child was fever-free for 24 hours. The children were followed for an average of about 2 years, by which time 90 percent of all febrile seizures recur. Study results showed that diazepam reduced the risk of febrile seizure recurrence by at least 44 percent and perhaps by as much as 82 percent.
In the study, Rosman and his colleagues found no serious side effects using diazepam. Children in the study often reported mild side effects, such as lethargy and unsteadiness, which were usually short-lived. The side effects always disappeared with a reduction in drug dosage.
"This approach is exactly what we've been looking for to treat children with febrile seizures," said Dr. Rosman. "It is extremely safe and strikingly effective. Based on their numbers of fevers, most children need to take the medicine for only a few days several times a year."
The investigators stressed the need for caregivers to give the drug at the first sign of fever. "In order to be successful, this treatment requires the active participation of caregivers, who must be watchful for any signs of illness in the child," said Rosman.
In some cases, children had a seizure before the parent had a chance to give medication. In cases where fever was recognized early, however, the treatment had its greatest effect.
The NINDS, one of the National Institutes of Health located in Bethesda, Md., is the nation's principle supporter of research on the brain and nervous system and a lead agency for the presidentially designated Decade of the Brain. The Institute conducts and supports a broad program of basic and clinical neurological investigations into seizure disorders at leading biomedical research institutions.
* N. Paul Rosman, M.D., Theodore Colton, Sc.D., Jan Labazzo, R.N.C., M.S., Paula L. Gilbert, B.S., Nancy B. Gardella, B.A., Edward M. Kaye, M.D., Carla Van Bennekom, M.P.H., Michael R. Winter, M.P.H. A Controlled Trial of Diazepam Administered During Febrile Illnesses to Prevent Recurrence of Febrile Seizures. The New England Journal of Medicine, July 8, 1993, pp. 79-84.
Last Modified August 7, 2009