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Practice Parameter: Pharmacological Treatment of migraine headache in children and adolescents

Objective of the guideline. To review evidence on the pharmacological treatments of migraine headache in children and adolescents. Non-pharmacological treatments and biobehavioral measures are not addressed in the guideline. . Methods of evidence review. The authors searched databases, including M

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Practice Parameter: Pharmacological Treatment of migraine headache in children and adolescents

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    1. Practice Parameter: Pharmacological Treatment of migraine headache in children and adolescents Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society D. Lewis, MD; S. Ashwal, MD; A. Hershey, MD; D. Hirtz, MD; M. Yonker, MD; S. Silberstein, MD Published in Neurology 2004;63:2215-2224

    2. Objective of the guideline To review evidence on the pharmacological treatments of migraine headache in children and adolescents. Non-pharmacological treatments and biobehavioral measures are not addressed in the guideline.

    3. Methods of evidence review The authors searched databases, including MEDLINE and CURRENT CONTENTS for relevant articles published from 1980 through December of 2003. The age qualifier of three years to 18 years was selected, as this is the age group when most children are seen for pediatric or neurological evaluation.

    4. Methods of evidence review Authors reviewed 166 articles and abstracts, which were identified for this project. In addition, bibliographies of the articles cited were checked for additional pertinent references. Each of the selected articles abstracted and classified by at least two committee members. Individual committee members reviewed titles and abstracts for content and relevance. Relevant position papers from professional organizations were also reviewed.

    5. AAN Strength of evidence

    6. AAN Strength of evidence

    7. AAN Translation of evidence to level of recommendation

    8. Introduction Migraine headaches are common in children; their frequency increases through adolescence. The mean age of onset is 7.2 years for boys and 10.9 years for girls, with prevalence rates reported at: 3% for children age 3-7 years 4-11% for children age 7-11 years 8-23% for children age 11-15 plus years

    9. Introduction Evaluation includes a thorough medical and family history and a complete physical examination. Diagnosis and assessment of symptoms is complicated by the inability of children to articulate their complaints. Other infectious, allergic, or gastrointestinal disorders of childhood may mimic symptoms of migraine. They difficulty of treating migraine in children is using medications that have shown efficacy in adults, however, the appropriate safety and efficacy studies have not been conducted in children and adolescents.

    10. Introduction 2004 International Headache Society classification of headache disorders; the criteria for pediatric migraine without aura: Greater than or equal to five attacks fulfilling features B-D Headache attack lasting one to 72 hours Headache has at least two of the following four features: Either bilateral or unilateral (frontal/temporal) location Pulsating quality Moderate to severe intensity Aggravated by routine physical activities At least one of the following accompanies headache: Nausea and/or vomiting Photophobia and phonophobia (may be inferred from their behavior)

    11. Acute Pharmacologic Treatment

    12. Acute Pharmacologic Treatment Recommended general principles for treatment of acute migraine headache include the following: Treat attacks rapidly and consistently without recurrence Restore the patients ability to function Minimize the use of back-up and rescue medications Optimize self-care and reduce subsequent use of resources Be cost-effective for overall management Have minimal or no adverse events

    13. Clinical questions How safe and tolerable are acute migraine medications in children and adolescents? What are the effects on acute headache pain of medications taken during the attack?

    14. Class I Evidence

    15. Class I Evidence

    16. Class I Evidence

    17. Conclusions For the acute treatment of migraine headaches in children, both ibuprofen and acetaminophen have been shown to be safe and effective. Sumatriptan is the only 5HT1 agonist that has proven effective for the treatment of children and adolescents with migraine with the nasal spray having the most favorable profile. There is only class IV evidence for effectiveness of subcutaneous sumatriptan. Oral triptan agents have not demonstrated efficacy in class I studies.

    18. Recommendations Ibuprofen is effective and should be considered for the acute treatment of migraine in children. (Class I, Level A) Acetaminophen is probably effective and should be considered for the acute treatment of migraine in children. (Class I, Level B)

    19. Recommendations Sumatriptan nasal spray is effective and should be considered for the acute treatment of migraine in adolescents. (Class I, Level A) There is no supporting data for the use of any oral triptan preparations in children or adolescents. (Class IV, Level U) There is inadequate data to make a judgement on the efficacy of subcutaneous sumatriptan. (Class IV, Level U)

    20. Preventive Pharmacologic Treatments

    21. Preventive Pharmacologic Treatments General principles related to the goals of migraine preventive therapies are to: Reduce attack frequency, severity, and duration Improve responsiveness to treatment of acute attacks Improve function, reduce disability and improve the patients quality of life

    22. Clinical Questions What are the effects on the frequency and/or severity of migraine attacks of medications taken on a daily basis for prevention of migraine? How safe and tolerable are preventive migraine medications in children and adolescents? How do the efficacy and tolerability of preventive medications for migraine compare to those for placebo?

    23. Class I and II Evidence

    24. Class II Evidence

    25. Conclusions Flunarizine was studied in one class I trial and is probably effective but is unavailable in the US. The evidence is insufficient to determine efficacy for the antihistamine cyproheptadine, the antidepressant amitriptyline, and the anticonvulsant agents valproic acid, topiramate, and levetiracetam for prevention of pediatric migraine. There is conflicting class II evidence regarding propranolol and trazodone. Clonidine, pizotifen, nimodipine and timolol were not shown to be more effective than placebo.

    26. Recommendations Flunarizine is probably effective for preventive therapy and can be considered for this purpose but it is not available in the United States. (Class I, Level B) There is insufficient evidence to make any recommendations concerning the use of: (Class IV, Level U) Cyproheptadine Amitriptyline Divalproex sodium Topiramate Levetiracetam.

    27. Recommendations Recommendations cannot be made concerning propranalol or trazodone for preventive therapy as the evidence is conflicting. (Class II, level U) Pizotifen and nimodipine (Class I, Level B) and clonidine and timolol (Class II, Level B) did not show efficacy and are not recommended.

    28. Future Research

    29. Standardized criteria: For the diagnosis of migraine headaches in children and adolescents are needed to facilitate proper diagnosis and to provide a case definition that could be used as part of therapeutic clinical trials. Of the responses to treatment of migraine in children and adolescents need to be established that are related to the frequency, duration, severity, and disability of headaches.

    30. The safety and efficacy of currently available medications used to treat migraine headaches in adults need to be established in children and adolescents, particularly the dose and age range in which these medications are deemed safe and effective to use. Failure of an agent for acute or preventive therapy to demonstrate efficacy to a statistically significant degree does not imply that these medications have no role in the pediatric population and their use must be based upon good clinical judgment.

    31. It is essential that multi-centered, placebo-controlled clinical trials be conducted to assess the safety, tolerability, and efficacy of medications used for the acute and preventive treatment of pediatric and adolescent migraine. Efforts must be made to develop novel and innovative study designs which will address the critical issue of high placebo response rates encountered in clinical trials in children and adolescents which has proven to be the major impediment to demonstration of efficacy.

    32. There are no epidemiological studies of the incidence or prevalence of status migraine [defined by the International Headache Society as a prolonged attack (= 72 hours) of unremitting headache] in children or adolescents. These epidemiological studies are needed, as well as treatment studies directed at this clinical entity. It will be important to understand the variations in effects of treatments by age and gender.

    33. Participants AAN Quality Standards Subcommittee Members Gary Franklin, MD, MPH (Co-Chair); Gary Gronseth, MD (Co-Chair); Charles E. Argoff, MD; Steven A. Ashwal, MD (ex-officio); Christopher Bever, Jr., MD; Jody Corey-Bloom, MD, PhD; John D. England, MD; Jacqueline French, MD (ex-officio); Gary H. Friday, MD; Michael J. Glantz, MD; Deborah Hirtz, MD; Donald J. Iverson, MD; David J. Thurman, MD; Samuel Wiebe, MD; William J. Weiner, MD, and Catherine Zahn, MD (ex-officio). CNS Practice Committee Members Carmela Tardo, MD (Chair); Bruce Cohen, MD (Vice-Chair); Elias Chalhub, MD; Roy Elterman, MD; Murray Engel, MD; Bhuwan P. Garg, MD; Brian Grabert, MD; Annette Grefe, MD; Michael Goldstein, MD; David Griesemer, MD; Betty Koo, MD; Edward Kovnar, MD; Leslie Anne Morrison, MD; Colette Parker MD; Ben Renfroe, MD; Anthony Riela, MD; Michael Shevell, MD; Shlomo Shinnar, MD; Herald Silverboard, MD; Russell Snyder, MD; Dean Timmons, MD; Greg Yim, MD; and Mary Anne Whelan, MD.

    34. To view the entire guideline and additional AAN guidelines visit: www.aan.com/professionals/practice/index/cfm Published in Neurology 2004;63:2215-2224

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