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Guideline Summary NGC-8181

Guideline Title Febrile seizures: clinical practice guideline for the long-term management of the child with simple febrile seizures. Bibliographic Source(s) Steering Committee on Quality Improvement and Management, Subcommittee on Febrile Seizures. Febrile seizures: clinical practice guideline for the long-termmanagementofthechildwithsimplefebrileseizures.Pediatrics2008 Jun;121(6):1281-6. PubMed Guideline Status This is the current release of the guideline. This guideline updates a previous version: Practice parameter: long-term treatment of the child with simple febrile seizures. American Academy of Pediatrics. Committee on Quality Improvement, Subcommittee on Febrile Seizures. Pediatrics 1999 Jun;103(6 Pt 1):1307-9. [17 references] 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.

Scope
Disease/Condition(s) Simple febrile seizure
Note: 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.

Guideline Category Assessment of Therapeutic Effectiveness Management Risk Assessment Treatment Clinical Specialty Emergency Medicine Family Practice Neurology Pediatrics Intended Users Physicians Guideline Objective(s) To address the risks and benefits of both continuous and intermittent anticonvulsant therapy as well as the use of antipyretics in children with simple febrile seizures Target Population Febrile children between the ages of 6 and 60 months who do not have an intracranial infection, metabolic disturbance, or history of afebrile seizures Interventions and Practices Considered 1.Continuousanticonvulsanttherapywithagentssuchasphenobarbital,primidone,valproicacidorcarbamazepine (considered, but not recommended) 2.Intermittenttherapywithdiazepam(considered,butnotrecommended) 3.Antipyretictherapy(considered,butnotrecommended) Major Outcomes Considered
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Recurrenceofseizures Adverseeffectsoftreatmentoptions

Methodology
Methods Used to Collect/Select the Evidence

Major Outcomes Considered

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Recurrenceofseizures Adverseeffectsoftreatmentoptions

Methodology
Methods Used to Collect/Select the Evidence Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence A comprehensive review of the evidence-based literature 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. Number of Source Documents 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. An additional 65 articles were reviewed and abstracted for the update. Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Evidence Quality A: Well-designed randomized controlled trials (RCTs) or diagnostic studies on relevant populations B: RCTs or diagnostic studies with minor limitations; overwhelmingly consistent evidence from observational studies C: Observational studies (case-control and cohort design) D: Expert opinion, case reports, reasoning from first principles X: Exceptional situations which validating studies cannot be performed and there is a clear preponderance of benefit or harm Methods Used to Analyze the Evidence Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Emphasis was placed on articles that differentiated simple 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 forthcoming technical report (the initial technical report can be accessed at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;103/6/e86 Documents" field in this summary.) Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations To update the clinical practice guideline on the treatment of children with simple febrile seizures, the American Academy of Pediatrics (AAP) reconvened the Subcommittee on Febrile Seizures. The committee was chaired by a child neurologist and consisted of a neuroepidemiologist, 2 additional child neurologists, and a practicing pediatrician. The AAP established a partnership with the University 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) effectiveness of antipyretics in preventing recurrent febrile seizures, and (4) adverse effects of either continuous or intermittent anticonvulsant therapy. The evidence-based approach to guideline development requires that the evidence in support of a recommendation be identified, appraised, and summarized and that an explicit link between evidence and recommendations be defined. Evidence-based recommendations reflect the quality of evidence and the balance of benefit and harm that is anticipated with the recommendation is followed. AAP policy statement "Classifying Recommendations for Clinical Practice Guidelines" was followed in designating levels of recommendations (see "Availability of Companion Documents" field). Rating Scheme for the Strength of the Recommendations Guideline Definitions for Evidence-Based Statements
Statement Definition Implication

). (See also "Availability of Companion

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

Clinicians would be prudent to

Rating Scheme for the Strength of the Recommendations 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. 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 would be prudent to follow a recommendation but should remain alert to new information and sensitive to patient preferences Clinicians should consider the option in their decision-making, and patient preference may have a substantial role. Clinicians should be alert to new published evidence that clarifies the balance of benefit versus harm.

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.

Note: Figure 1 in the original guideline document illustrates the integration of evidence-quality appraisal with an assessment of the anticipated balance between benefits and harms to designate a policy as a strong recommendation, recommendation, option, or no recommendation.

Cost Analysis A formal cost analysis was not performed and published cost analyses were not reviewed. Method of Guideline Validation External Peer Review Internal Peer Review Description of Method of Guideline Validation The guideline was reviewed by members of the American Academy of Pediatrics (AAP) Steering Committee on Quality Improvement and Management; members of the AAP Sections on Neurology, Pediatric Emergency Medicine, Developmental and Behavioral Pediatrics, and Epidemiology; members of the AAP Committees on Pediatric 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.

Recommendations
Major Recommendations 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.
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Aggregateevidencequality:B(randomized,controlledtrialsanddiagnosticstudieswithminorlimitations).

Benefit:preventionofrecurrentfebrileseizures,whicharenotharmfulanddonotsignificantlyincreasetherisk for development of future epilepsy. Harm:adverseeffectsincludingrarefatalhepatotoxicity(especiallyinchildrenyoungerthan2yearswhoarealso at greatest risk of febrile seizures), thrombocytopenia, weight loss and gain, gastrointestinal disturbances, and pancreatitis with valproic acid and hyperactivity, irritability, lethargy, sleep disturbances, and hypersensitivity reactions with phenobarbital; lethargy, drowsiness, and ataxia for intermittent diazepam as well as the risk of masking an evolving central nervous system infection.
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Benefits/harmsassessment:preponderanceofharmoverbenefit. Policylevel:recommendation.

Definitions: 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. 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 would be prudent to follow a recommendation but should remain alert to new information and sensitive to patient preferences Clinicians should consider the option in their decision-making, and patient preference may have a substantial role. Clinicians should be alert to new published evidence that clarifies the balance of benefit versus

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.

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. 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 would be prudent to follow a recommendation but should remain alert to new information and sensitive to patient preferences Clinicians should consider the option in their decision-making, and patient preference may have a substantial role. Clinicians should be alert to new published evidence that clarifies the balance of benefit versus harm.

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.

Note: Figure 1 in the original guideline document illustrates the integration of evidence-quality appraisal with an assessment of the anticipated balance between benefits and harms to designate a policy as a strong recommendation, recommendation, option, or no recommendation.

Clinical Algorithm(s) None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for the recommendation (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits Optimizingpractitionerunderstandingofthescientificbasisforusingoravoidingvariousproposedtreatmentsfor children with simple febrile seizures
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Improvingthehealthofchildrenwithsimplefebrileseizuresbyavoidingtherapieswithhighpotentialforadverse effects and no demonstrated ability to improve children's long-term outcomes

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Reducingcostsbyavoidingtherapiesthatwillnotdemonstrablyimprovechildren'slong-term outcomes Helpingthepractitionereducatecaregiversaboutthelowrisksassociatedwithsimplefebrileseizures

Potential Harms Not stated

Qualifying Statements
Qualifying Statements This guideline is designed to assist pediatricians by providing an analytic framework for decisions regarding possible therapeutic interventions in this patient 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.

Implementation of the Guideline

Description of Implementation Strategy An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need Getting Better IOM Domain Effectiveness Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s) Steering Committee on Quality Improvement and Management, Subcommittee on Febrile Seizures. Febrile seizures: clinical practice guideline for the long-termmanagementofthechildwithsimplefebrileseizures.Pediatrics2008 Jun;121(6):1281-6. PubMed Adaptation Not applicable: The guideline was not adapted from another source. Date Released

Bibliographic Source(s) Steering Committee on Quality Improvement and Management, Subcommittee on Febrile Seizures. Febrile seizures: clinical practice guideline for the long-termmanagementofthechildwithsimplefebrileseizures.Pediatrics2008 Jun;121(6):1281-6. PubMed Adaptation Not applicable: The guideline was not adapted from another source. Date Released 1999 Jun (revised 2008 Jun) Guideline Developer(s) American Academy of Pediatrics - Medical Specialty Society Source(s) of Funding American Academy of Pediatrics Guideline Committee Steering Committee on Quality Improvement and Management, Subcommittee on Febrile Seizures Composition of Group That Authored the Guideline Subcommittee on Febrile Seizures, 20022008: Patricia K. Duffner, MD, Chairperson; Robert J. Baumann, MD, Methodologist; Peter Berman, MD; John L. Green, MD; Sanford Schneider, MD Steering Committee on Quality Improvement and Management, 20072008: Elizabeth S. Hodgson, MD, Chairperson; Gordon B. Glade, MD; Norman "Chip" Harbaugh, Jr, MD; Thomas K. McInerny, MD; Marlene R. Miller, MD, MSc; Virginia A. Moyer, MD, MPH; Xavier D. Sevilla, MD; Lisa Simpson, MB, BCh, MPH; Glenn S. Takata, MD Liaisons: Denise Dougherty, PhD, Agency for Healthcare Research and Quality; Daniel R. Neuspiel, MD, Section on Epidemiology; Ellen Schwalenstocker, MBA, National Association of Children's Hospitals and Related Institutions Staff: Caryn Davidson, MA Financial Disclosures/Conflicts of Interest All panel members reviewed and signed the American Academy of Pediatrics (AAP) voluntary disclosure and conflict-ofinterest form. Guideline Status This is the current release of the guideline. This guideline updates a previous version: Practice parameter: long-term treatment of the child with simple febrile seizures. American Academy of Pediatrics. Committee on Quality Improvement, Subcommittee on Febrile Seizures. Pediatrics 1999 Jun;103(6 Pt 1):1307-9. [17 references] 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. Guideline Availability Electronic copies: Available from the American Academy of Pediatrics (AAP) Policy Web site .

Print copies: Available from American Academy of Pediatrics, 141 Northwest Point Blvd., P.O. Box 927, Elk Grove Village, IL 60009-0927. Availability of Companion Documents The following are available:
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BaumannRJ.Technicalreport:treatmentofthechildwithsimplefebrileseizures.Pediatrics1999Jun103(6). .

Available from the American Academy of Pediatrics Policy Web site

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Classifyingrecommendationsforclinicalpractice.Policystatement.Pediatrics2004Sept114(3).Availablefrom .

the American Academy of Pediatrics Policy Web site

Print copies: Available from American Academy of Pediatrics, 141 Northwest Point Blvd., P.O. Box 927, Elk Grove Village, IL 60009-0927. Patient Resources None available NGC Status This summary was completed by ECRI on August 29, 1999. The information was verified by the guideline developer on December 15, 1999. This summary was updated by ECRI Institute on February 24, 2011. Copyright Statement This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please contact the Permissions Editor, American Academy of Pediatrics (AAP), 141 Northwest Point Blvd, Elk Grove Village, IL 60007.

NGC Status This summary was completed by ECRI on August 29, 1999. The information was verified by the guideline developer on December 15, 1999. This summary was updated by ECRI Institute on February 24, 2011. Copyright Statement This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please contact the Permissions Editor, American Academy of Pediatrics (AAP), 141 Northwest Point Blvd, Elk Grove Village, IL 60007.

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