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the Long-term Management of the Child With Sim

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the Long-term Management of the Child With Sim DOI: 10.1542/peds.2008-0939 2008;121;1281-1286 Pediatrics Febrile Seizures Steering Committee on Quality Improvement and Management, Subcommittee on the Child With Simple Febrile Seizures Febrile Seizures: Clinical Practice Guideline for the Long-term Managem...
the Long-term Management of the Child With Sim
DOI: 10.1542/peds.2008-0939 2008;121;1281-1286 Pediatrics Febrile Seizures Steering Committee on Quality Improvement and Management, Subcommittee on the Child With Simple Febrile Seizures Febrile Seizures: Clinical Practice Guideline for the Long-term Management of http://www.pediatrics.org/cgi/content/full/121/6/1281 located on the World Wide Web at: The online version of this article, along with updated information and services, is rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275. Grove Village, Illinois, 60007. Copyright © 2008 by the American Academy of Pediatrics. All and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk publication, it has been published continuously since 1948. PEDIATRICS is owned, published, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly . Provided by Shantou University on May 26, 2010 www.pediatrics.orgDownloaded from CLINICAL PRACTICE GUIDELINE Febrile Seizures: Clinical Practice Guideline for the Long-term Management of the Child With Simple Febrile Seizures Steering Committee on Quality Improvement andManagement, Subcommittee on Febrile Seizures ABSTRACT Febrile seizures are the most common seizure disorder in childhood, affecting 2% to 5% of children between the ages of 6 and 60 months. Simple febrile seizures are defined as brief (�15-minute) generalized seizures that occur once during a 24-hour period in a febrile child who does not have an intracranial infection, metabolic disturbance, or history of afebrile seizures. This guideline (a revision of the 1999 American Academy of Pediatrics practice parameter [now termed clinical practice guideline] “The Long-term Treatment of the Child With Simple Febrile Seizures”) addresses the risks and benefits of both continuous and intermittent anticonvulsant therapy as well as the use of antipyretics in children with simple febrile seizures. It is designed to assist pediatricians by providing an analytic framework for decisions regarding possible therapeutic interventions in this pa- tient population. It is not intended to replace clinical judgment or to establish a protocol for all patients with this disorder. Rarely will these guidelines be the only approach to this problem. Pediatrics 2008;121:1281–1286 The expected outcomes of this practice guideline include: 1. optimizing practitioner understanding of the scientific basis for using or avoid- ing various proposed treatments for children with simple febrile seizures; 2. improving the health of children with simple febrile seizures by avoiding therapies with high potential for adverse effects and no demonstrated ability to improve children’s long-term outcomes; 3. reducing costs by avoiding therapies that will not demonstrably improve children’s long-term outcomes; and 4. helping the practitioner educate caregivers about the low risks associated with simple febrile seizures. The committee determined that with the exception of a high rate of recurrence, no long-term effects of simple febrile seizures have been identified. The risk of developing epilepsy in these patients is extremely low, although slightly higher than that in the general population. No data, however, suggest that prophylactic treatment of children with simple febrile seizures would reduce the risk, because epilepsy likely is the result of genetic predisposition rather than structural damage to the brain caused by recurrent simple febrile seizures. Although antipyretics have been shown to be ineffective in preventing recurrent febrile seizures, there is evidence that continuous anticonvulsant therapy with phenobarbital, primidone, or valproic acid and intermittent therapy with diazepam are effective in reducing febrile-seizure recurrence. The potential toxicities associated with these agents, however, outweigh the relatively minor risks associated with simple febrile seizures. As such, the committee concluded that, on the basis of the risks and benefits of the effective therapies, neither continuous nor intermittent anticonvulsant therapy is recommended for children with 1 or more simple febrile seizures. INTRODUCTION Febrile seizures are seizures that occur in febrile children between the ages of 6 and 60 months who do not have an intracranial infection, metabolic disturbance, or history of afebrile seizures. Febrile seizures are subdivided into 2 categories: simple and complex. Simple febrile seizures last for less than 15 minutes, are generalized (without a focal component), and occur once in a 24-hour period, whereas complex febrile seizures are prolonged (�15 minutes), are focal, or occur more than once in 24 hours.1 Despite the frequency of febrile seizures (2%–5%), there is no unanimity of opinion about management options. This clinical practice guideline addresses potential therapeutic interventions in neurologically normal children with simple febrile seizures. It is not intended for patients with complex febrile seizures and does not pertain to children with previous neurologic insults, known central nervous system abnor- www.pediatrics.org/cgi/doi/10.1542/ peds.2008-0939 doi:10.1542/peds.2008-0939 All clinical reports from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time. The guidance in this report does not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. KeyWord fever Abbreviation AAP—American Academy of Pediatrics PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright © 2008 by the American Academy of Pediatrics PEDIATRICS Volume 121, Number 6, June 2008 1281 . Provided by Shantou University on May 26, 2010 www.pediatrics.orgDownloaded from malities, or a history of afebrile seizures. This clinical practice guideline is a revision of a 1999 American Acad- emy of Pediatrics (AAP) clinical practice parameter, “The Long-term Treatment of the Child With Simple Febrile Seizures.”2 For a child who has experienced a simple febrile seizure, there are potentially 4 adverse outcomes that theoretically may be altered by an effective therapeutic agent: (1) decline in IQ; (2) increased risk of epilepsy; (3) risk of recurrent febrile seizures; and (4) death. Neither a decline in IQ, academic performance or neurocognitive inattention nor behavioral abnormalities have been shown to be a consequence of recurrent simple febrile seizures.3 Ellenberg and Nelson4 studied 431 children who experienced febrile seizures and observed no sig- nificant difference in their learning compared with sib- ling controls. In a similar study by Verity et al,5 303 children with febrile seizures were compared with con- trol children. No difference in learning was identified, except in those children who had neurologic abnormal- ities before their first seizure. The second concern, increased risk of epilepsy, is more complex. Children with simple febrile seizures have approximately the same risk of developing epilepsy by the age of 7 years as does the general population (ie, 1%).6 However, children who have had multiple simple febrile seizures, are younger than 12 months at the time of their first febrile seizure, and have a family history of epilepsy are at higher risk, with generalized afebrile sei- zures developing by 25 years of age in 2.4%.7 Despite this fact, no study has demonstrated that successful treatment of simple febrile seizures can prevent this later development of epilepsy, and there currently is no evi- dence that simple febrile seizures cause structural dam- age to the brain. Indeed, it is most likely that the in- creased risk of epilepsy in this population is the result of genetic predisposition. In contrast to the slightly increased risk of developing epilepsy, children with simple febrile seizures have a high rate of recurrence. The risk varies with age. Chil- dren younger than 12 months at the time of their first simple febrile seizure have an approximately 50% prob- ability of having recurrent febrile seizures. Children older than 12 months at the time of their first event have an approximately 30% probability of a second febrile seizure; of those who do have a second febrile seizure, 50% have a chance of having at least 1 additional recur- rence.8 Finally, there is a theoretical risk of a child dying during a simple febrile seizure as a result of documented injury, aspiration, or cardiac arrhythmia, but to the com- mittee’s knowledge, it has never been reported. In summary, with the exception of a high rate of recurrence, no long-term adverse effects of simple febrile seizures have been identified. Because the risks associ- ated with simple febrile seizures, other than recurrence, are so low and because the number of children who have febrile seizures in the first few years of life is so high, to be commensurate, a proposed therapy would need to be exceedingly low in risks and adverse effects, inexpensive, and highly effective. METHODS To update the clinical practice guideline on the treat- ment of children with simple febrile seizures, the AAP reconvened the Subcommittee on Febrile Seizures. The committee was chaired by a child neurologist and con- sisted of a neuroepidemiologist, 2 additional child neu- rologists, and a practicing pediatrician. All panel mem- bers reviewed and signed the AAP voluntary disclosure and conflict-of-interest form. The guideline was re- viewed by members of the AAP Steering Committee on Quality Improvement andManagement; members of the AAP Sections on Neurology, Pediatric Emergency Med- icine, Developmental and Behavioral Pediatrics, and Epidemiology; members of the AAP Committees on Pe- diatric Emergency Medicine and Medical Liability and Risk Management; members of the AAP Councils on Children With Disabilities and Community Pediatrics; and members of outside organizations including the Child Neurology Society and the American Academy of Neurology. A comprehensive review of the evidence-based liter- ature published since 1998 was conducted with the aim of addressing possible therapeutic interventions in the management of children with simple febrile seizures. The review focused on both the efficacy and potential adverse effects of the proposed treatments. Decisions were made on the basis of a systematic grading of the quality of evidence and strength of recommendations. The AAP established a partnership with the Univer- sity of Kentucky (Lexington, KY) to develop an evidence report, which served as a major source of information for these practice-guideline recommendations. The specific issues addressed were (1) effectiveness of continuous anticonvulsant therapy in preventing recurrent febrile seizures, (2) effectiveness of intermittent anticonvulsant therapy in preventing recurrent febrile seizures, (3) ef- fectiveness of antipyretics in preventing recurrent febrile seizures, and (4) adverse effects of either continuous or intermittent anticonvulsant therapy. In the original practice parameter, more than 300 medical journal articles reporting studies of the natural history of simple febrile seizures or the therapy of these seizures were reviewed and abstracted.2 An additional 65 articles were reviewed and abstracted for the update. Emphasis was placed on articles that differentiated sim- ple febrile seizures from other types of seizures, that carefully matched treatment and control groups, and that described adherence to the drug regimen. Tables were constructed from the 65 articles that best fit these criteria. A more comprehensive review of the literature on which this report is based can be found in a forth- coming technical report (the initial technical report can be accessed at http://aappolicy.aappublications.org/cgi/ content/full/pediatrics;103/6/e86). The technical report also will contain dosing information. The evidence-based approach to guideline development requires that the evidence in support of a recommendation be identified, appraised, and summarized and that an ex- plicit link between evidence and recommendations be de- fined. Evidence-based recommendations reflect the quality of evidence and the balance of benefit and harm that is 1282 AMERICAN ACADEMY OF PEDIATRICS . Provided by Shantou University on May 26, 2010 www.pediatrics.orgDownloaded from anticipated when the recommendation is followed. The AAP policy statement “Classifying Recommendations for Clinical Practice Guidelines”9 was followed in designating levels of recommendations (see Fig 1 and Table 1). RECOMMENDATION On the basis of the risks and benefits of the effective therapies, neither continuous nor intermittent anticon- vulsant therapy is recommended for children with 1 or more simple febrile seizures. ● Aggregate evidence quality: B (randomized, controlled trials and diagnostic studies with minor limitations). ● Benefit: prevention of recurrent febrile seizures, which are not harmful and do not significantly in- crease the risk for development of future epilepsy. ● Harm: adverse effects including rare fatal hepatotox- icity (especially in children younger than 2 years who are also at greatest risk of febrile seizures), thrombo- cytopenia, weight loss and gain, gastrointestinal dis- turbances, and pancreatitis with valproic acid and hy- peractivity, irritability, lethargy, sleep disturbances, and hypersensitivity reactions with phenobarbital; lethargy, drowsiness, and ataxia for intermittent diaz- epam as well as the risk of masking an evolving central nervous system infection. ● Benefits/harms assessment: preponderance of harm over benefit. ● Policy level: recommendation. BENEFITS AND RISKS OF CONTINUOUS ANTICONVULSANT THERAPY Phenobarbital Phenobarbital is effective in preventing the recurrence of simple febrile seizures.10 In a controlled double-blind study, daily therapy with phenobarbital reduced the rate of subsequent febrile seizures from 25 per 100 subjects per year to 5 per 100 subjects per year.11 For the agent to be effective, however, it must be given daily and main- tained in the therapeutic range. In a study by Farwell et al,12 for example, children whose phenobarbital levels were in the therapeutic range had a reduction in recur- rent seizures, but because noncompliance was so high, an overall benefit with phenobarbital therapy was not identified. The adverse effects of phenobarbital include hyperac- tivity, irritability, lethargy, sleep disturbances, and hy- persensitivity reactions. The behavioral adverse effects FIGURE 1 Integrating evidence-quality appraisal with an assessment of the anticipated balance between benefits and harms if a policy is conducted leads to designation of a policy as a strong recommendation, recommendation, option, or no recommendation. RCT indi- cates randomized, controlled trial. TABLE 1 Guideline Definitions for Evidence-Based Statements Statement Definition Implication Strong recommendation A strong recommendation in favor of a particular action is made when the anticipated benefits of the recommended intervention clearly exceed the harms (as a strong recommendation against an action is made when the anticipated harms clearly exceed the benefits) and the quality of the supporting evidence is excellent. In some clearly identified circumstances, strong recommendations may be made when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present. Recommendation A recommendation in favor of a particular action is made when the anticipated benefits exceed the harms but the quality of evidence is not as strong. Again, in some clearly identified circumstances, recommendations may be made when high-quality evidence is impossible to obtain but the anticipated benefits outweigh the harms. Clinicians would be prudent to follow a recommendation but should remain alert to new information and sensitive to patient preferences. Option Options define courses that may be taken when either the quality of evidence is suspect or carefully performed studies have shown little clear advantage to 1 approach over another. Clinicians should consider the option in their decision- making, and patient preference may have a substantial role. No recommendation No recommendation indicates that there is a lack of pertinent published evidence and that the anticipated balance of benefits and harms is presently unclear. Clinicians should be alert to new published evidence that clarifies the balance of benefit versus harm. PEDIATRICS Volume 121, Number 6, June 2008 1283 . Provided by Shantou University on May 26, 2010 www.pediatrics.orgDownloaded from may occur in up to 20% to 40% of patients and may be severe enough to necessitate discontinuation of the drug.13–16 Primidone Primidone, in doses of 15 to 20 mg/kg per day, has also been shown to reduce the recurrence rate of febrile seizures.17,18 It is of interest that the derived phenobar- bital level in a Minigawa and Miura study17 was below therapeutic (16 �g/mL) in 29 of the 32 children, sug- gesting that primidone itself may be active in preventing seizure recurrence. As with phenobarbital, adverse ef- fects include behavioral disturbances, irritability, and sleep disturbances.18 Valproic Acid In randomized, controlled studies, only 4% of children taking valproic acid, as opposed to 35% of control sub- jects, had a subsequent febrile seizure. Therefore, val- proic acid seems to be at least as effective in preventing recurrent simple febrile seizures as phenobarbital and significantly more effective than placebo.19–21 Drawbacks to therapy with valproic acid include its rare association with fatal hepatotoxicity (especially in children younger than 2 years, who are also at greatest risk of febrile seizures), thrombocytopenia, weight loss and gain, gastrointestinal disturbances, and pancreatitis. In studies in which children received valproic acid to prevent recurrence of febrile seizures, no cases of fatal hepatotoxicity were reported.15 Carbamazepine Carbamazepine has not been shown to be effective in preventing the recurrence of simple febrile seizures. Antony and Hawke13 compared children who had been treated with therapeutic levels of either phenobarbital or carbamazepine, and 47% of the children in the carbam- azepine-treated group had recurrent seizures compared with only 10% of those in the phenobarbital group. In another study, Camfield et al22 treated children (whose conditions failed to improve with phenobarbital ther- apy) with carbamazepine. Despite good compliance, 13 of the 16 children treated with carbamazepine had a recurrent febrile seizure within 18 months. It is theoret- ically possible that these excessively high rates of recur- rences might have been attributable to adverse effects of carbamazepine. Phenytoin Phenytoin has not been shown to be effective in pre- venting the recurrence of simple febrile seizures, even when the agent is in the therapeutic range.23,24 Other anticonvulsants have not been studied for the continu- ous treatment of simple febrile seizures. BENEFITS AND RISKS OF INTERMITTENT ANTICONVULSANT THERAPY Diazepam A double-blind controlled study of patients with a his- tory of febrile seizures demonstrated that administration of oral diazepam (given at the time of fever) could re- duce the recurrence of febrile seizures. Children with a history of febrile seizures were given either oral diaze- pam (0.33 mg/kg, every 8 hours for 48 hours) or a placebo at the time of fever. The risk of febrile seizures per person-year was decreased 44% with diazepam.25 In a more recent study, children with a history of febrile seizures were given oral diazepam at the time of fever and
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