When it comes to drug therapy for migraines, don't treat children like little adults.
There are currently no agents approved by the FDA for the acute treatment of migraine in children or adolescents. New practice guidelines developed by the American Academy of Neurology (AAN) support the use of conventional analgesic medications, such as ibuprofen and acetaminophen, for acute migraine pain in children aged 6 years and older but do not recommend most of the newer drugs being used to prevent and treat adult migraine pain.
One exception is sumatriptan nasal spray (Imitrex), which the guidelines recommend for treating migraine pain in children older than 12 years.
“It is not that the newer medications are ineffective in children and adolescents,” said lead author Donald W. Lewis, M.D. “Rather, they have been insufficiently studied in the pediatric population.” In fact, the most definitive conclusion the guideline authors reached was that there is a “clear and urgent need for methodologically sound randomized controlled trials for the use of prophylactic drugs in pediatric migraine,” Dr. Lewis said in an interview with CLINICAL NEUROLOGY NEWS.
Dr. Lewis, a pediatric neurologist at Children's Hospital of the King's Daughters in Norfolk, Va., and his coauthors reviewed the results of 166 placebo-controlled trials of migraine therapy conducted in children between the ages of 3 and 18 years during the last 2 decades. The evaluation included 5 agents for acute migraine treatment and 12 for migraine prevention. The authors used a four-tiered classification system to assess the quality of the available evidence, to determine whether the evidence supported specific recommendations, and, if it did, to gauge the strength of the recommendations (Neurology 2004;63:2215-24).
The treatment agents included in the evaluation were ibuprofen, acetaminophen, sumatriptan nasal spray, rizatriptan (Maxalt), and zolmitriptan (Zomig). The preventive agents were flunarizine (Sibelium), cyproheptadine (Periactin), amitriptyline (Elavil), divalproex sodium (Depakote), topiramate (Topamax), levetiracetam (Keppra), propranolol (Inderal), trazodone (Desyrel), pizotifen (Sandomigran), nimodipine (Nimotop), and clonidine (Catapres).
Of drugs to treat acute migraine, both ibuprofen and sumatriptan nasal spray were classified as effective, although the data for nasal sumatriptan only support a recommendation for use in adolescents. Acetaminophen was judged probably effective and also recommended for use. Both the oral triptan preparations as well as subcutaneous sumatriptan were not recommended because there were no data to support or discourage their use.
Only one of the preventive drugs—flunarizine—has been studied in rigorous controlled trials in children and was deemed by the guideline authors as “probably effective” in children. However, the calcium channel blocker is not available in the United States.
Of the remaining prophylactic agents, there is insufficient evidence to recommend cyproheptadine, amitriptyline, divalproex sodium, topiramate, or levetiracetam, according to the guidelines. Propranolol and trazodone are not recommended because of conflicting evidence, and pizotifen, nimodipine, and clonidine are not recommended because the data did not show them to be effective.
Given the prevalence of migraine headaches in children—up to 23% in 11- to 15-year-olds—“there is a disappointing lack of evidence to support pharmacologic interventions,” said Dr. Lewis. Although the failure of the various therapeutic and prophylactic drugs to demonstrate statistically significant efficacy does not preclude their use in the pediatric population, “good clinical judgment has to be used, particularly with respect to dosing and age ranges,” he said.
Fortunately, some proven adult interventions are effective, and the guidelines recommend their use in children as well.
“Not all children require drug treatment for migraines, and in fact it is often not the first line of attack and should never be the sole approach,” said Dr. Lewis. Lifestyle changes are often in order and can be very effective, he said. “In teens especially, poor diet, lack of sleep, too much caffeine, and school and social stress is a big problem. The first step is to modify these factors.”
Lifestyle information, including nutritional education, a prescription for daily exercise, and, when indicated, behavioral therapy, should be part of every migraine treatment protocol, as should a migraine calendar to record the frequency and intensity of migraine.
These steps help to ensure that each child gets the treatment that meets his or her individual needs.
“There is no one 'right' way to treat migraine in children,” Dr. Lewis said. “Interventions need to be tailored to the individual.”
One often overlooked key to the development of successful interventions, Dr. Lewis contended, is the fact that parents, teachers, caregivers, and physicians often don't recognize migraines in children—either because of a misperception that children don't experience migraines or because the children are not able to fully articulate the nature of the pain.