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

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


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 2004632215-2224

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
Class I Prospective, randomized, controlled clinical trial with masked outcome assessment, in a representative population. Where primary outcome(s) is/are clearly defined, exclusion/inclusion criteria are clearly defined, adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
6
AAN Strength of evidence
Class II Prospective matched group cohort study in a representative population with masked outcome assessment that meets criteria above OR a RCT in a representative population that lacks one of above criteria.
Class III All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome assessment is independent of patient treatment.
Class IV Evidence from uncontrolled studies, case series, case reports, or expert opinion.
7
AAN Translation of evidence to level of
recommendation
Level A Established as effective, ineffective or harmful for the given condition in the specified population.
Level B Probably effective, ineffective or harmful for the given condition in the specified population.
Level C Possibly effective, ineffective or harmful for the given condition in the specified population.
Level U Data inadequate or conflicting. Given current knowledge, treatment is unproven.
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
Author, Year Class Drug (NSAIDs and non-opiate analgesics ) Efficacy
Hamalainen, et al., 1997 (18) I Ibuprofen Active 68 Placebo 37 P-value lt.05
Lewis, et al., 2002 (19) I Ibuprofen Active 76 Placebo 53 P-value .006
Hamalainen, et al., 1997 (18) I  Acetaminophen Active 54 Placebo 37 Exact p-values not provided lt.05
15
Class I Evidence
Author, Year Class Drug (Triptrans) Efficacy
Ueberall, 1999 (20) I Sumatriptan, Nasal Active 85.7 Placebo 42.8 P-value .03
Winner, et al., 2000 (21) I Sumatriptan, Nasal Active 66 Placebo 53 Exact p-values not provided (.05)
Ahonen, et al., 2004 (22) I Sumatriptan, Nasal Active 64 Placebo 39 P-value .003
16
Class I Evidence
Author, Year Class Drug (Triptrans) Efficacy
Hamalainen, et al., 1997(25) I Sumatriptan, Oral Active 30 Placebo 22 P-value non-significant
Winner, et al., 2002 (26) I Oral Triptans, Rizatriptan Active 66 Placebo 56 P-value non-significant
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
Author, Year Class Drug (Antidepressants and Calcium Channel blockers) Efficacy
Gillies, et al., 1986 (36) I Antidepressant medications, Pizotifen Non-significant
Battostella, et al., 1993(35) II Antidepressant medications, Trazodone Non-significant
Sorge, et al., 1988 (42) I Calcium channel blockers, Flunarizine plt0.001, 75 had 75-100 reduction headache frequency
Battistella, et al 1990(41) I Calcium channel blockers, Nimodipine Non-significant
24
Class II Evidence
Author, Year Class Drug (Antihypertensive agents) Efficacy
Ludvigsson, 1974 (29) II Propranolol 81
Forsythe, et al., 1984 (30) II Propranolol Non-significant
Olness, et al., 1987 (31) II Propranolol Non-significant
Sills, et al., 1982 (32) II Clonidine Non-significant
Sillanpaa, 1977 (33) II Clonidine Active 32 Placebo 34 P-value Non-significant
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/practi
ce/index/cfm
  • Published in Neurology 2004632215-2224
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