Nasal sumatriptan is effective in treatment of migraine attacks in children: A randomized trial.
OBJECTIVE
To investigate the efficacy of nasal sumatriptan in migraine attacks of children and adolescents.


METHODS
A double-blind, placebo-controlled, two-way crossover trial was conducted in three hospital outpatient departments, with 8 to 17 year olds diagnosed with migraine serving as subjects (International Headache Society 1988). A single dose of sumatriptan nasal spray and a matching placebo were administered at home during two attacks. The sumatriptan dose was 10 mg for a body weight of 20 to 39 kg and 20 mg for those with a body weight of >/==" BORDER="0">40 kg. The primary efficacy endpoint was headache relief by two grades on a 5-grade face scale at 2 hours.


RESULTS
Eighty-three patients used both treatments and 11 only the first. At 2 hours, the primary endpoint was reached nearly twice as often after sumatriptan (n = 53/83; 64%) as after placebo (n = 32/83; 39%) (p = 0.003). Already at 1 hour, headache relief was seen more often after sumatriptan (n = 42/83; 51%) than after placebo (n = 24/83; 29%) (p = 0.014). The difference was even more obvious in patients who received the 20-mg dose as well as in the intention-to-treat analyses (n = 94). Other endpoints, including child's preference and using rescue medication, also favored sumatriptan. The most common adverse effect was a bad taste after sumatriptan, reported in 29% (n = 26/90) of the attacks. No serious adverse effects were observed.


CONCLUSIONS
Nasal sumatriptan is an effective and well-tolerated treatment for migraine attacks in children over 8 years of age.
Ahonen
Kati
K
Hospital for Children and Adolescents, Department of Clinical Pharmacology, University of Helsinki, Finland. Kati.Ahonen@hus.fi
Hämäläinen
Mirja L
ML
Rantala
Heikki
H
Hoppu
Kalle
K
D000281:Administration, Intranasal; D000293:Adolescent; D002648:Child; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy*; D009325:Nausea / Q000139:chemically induced; D010147:Pain Measurement / Q000187:drug effects; D055502:Secondary Prevention; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018170:Sumatriptan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D017366:Serotonin Receptor Agonists; D018170:Sumatriptan