Cover of Migraine in Children: Preventive Pharmacologic Treatments

Migraine in Children: Preventive Pharmacologic Treatments

Comparative Effectiveness Reviews, No. 108

Investigators: , MD, MS, , MD, , MPH, and , MD.

Minnesota Evidence-based Practice Center
Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 13-EHC065-EF

Structured Abstract


To assess the comparative effectiveness and safety of preventive pharmacologic treatments for community-dwelling children with episodic or chronic migraine.

Data sources:

We searched major electronic bibliographic databases, including Medline® and Cochrane Central Register of Controlled Trials, and trial registries up to May 20, 2012.

Review methods:

We performed a systematic review of original studies published in English that examined episodic or chronic migraine and rates of complete cessation or reduction of monthly migraine frequency by ≥50 percent, reduction in migraine-related disability, and improvement in quality of life with off-label drugs. (No preventive drugs were approved in children.) Also eligible were studies that compared drugs with nonpharmacologic interventions or drug management programs. We calculated absolute risk differences, pooled them with random-effects models, and calculated numbers of outcome events attributable to treatment effects per 1,000 treated.


Prevention of episodic migraine in children was examined in 24 publications of randomized controlled trials (RCTs) that enrolled 1,578 children and in 16 nonrandomized studies. Evidence was low strength due to risk of bias and imprecision. Propranolol was estimated to result in complete cessation of migraine attacks in 713 per 1,000 children treated (95-percent confidence interval [CI], 452 to 974) (one RCT). Trazodone (one RCT) and nimodipine (one RCT) decreased migraine days more effectively than placebo. Topiramate (two RCTs), divalproex (one RCT), and clonidine (one RCT) were no more effective than placebo in preventing migraine. Sodium valproate demonstrated no significant differences for migraine prevention or migraine-related disability compared with propranolol (two RCTs) or topiramate (one RCT). Metoprolol tended to be less effective than stress management in preventing migraine or reducing migraine severity (one RCT). Propranolol had less effect than self-hypnosis on absolute number of migraine attacks (one RCT). Multidisciplinary drug management was more effective than usual care in preventing migraine in children and adolescents (one RCT), but the effect was not sustained at 6 months. Divalproex sodium (one RCT) resulted in treatment discontinuation due to adverse effects more often than placebo. Treatment discontinuation due to adverse effects did not differ between topiramate (two RCTs), trazodone (one RCT), propranolol (one RCT), or clonidine (one RCT) and placebo. Topiramate increased risk of paresthesia, upper respiratory tract infection, and weight loss. No RCTs examined prevention of chronic migraine in children.


Limited low-strength evidence suggests that propranolol was more effective than placebo for preventing episodic migraine in children, with no bothersome adverse effects that could lead to treatment discontinuation. Long-term preventive benefits are unknown both for drugs and nonpharmacologic interventions. No studies examined quality of life or provided evidence for individualized treatment decisions. Future randomized trials of drugs with favorable benefits-to-harms ratio in adults are needed to identify effective and safe treatments to prevent episodic and chronic migraine in children.

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-07-10064-I. Prepared by: Minnesota Evidence-based Practice Center, Minneapolis, MN

Suggested citation:

Shamliyan TA, Kane RL, Ramakrishnan R, Taylor FR. Migraine in Children: Preventive Pharmacologic Treatments. Comparative Effectiveness Review No. 108. (Prepared by the University of Minnesota Evidence-based Practice Center under Contract No. 290-2007-10064-I.) AHRQ Publication No. 13-EHC065-EF. Rockville, MD: Agency for Healthcare Research and Quality; June 2013.

This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-07-10064-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.


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Bookshelf ID: NBK148703PMID: 23865090