Objective: Preventive therapy in migraine must be started with frequent or disabling headaches in children,
while, no drugs have been approved for migraine preventive therapy of them up to now. The aim of the present research
was to investigate safety and efficacy of melatonin in pediatric migraine prophylaxis.
Methods: In a quasi- experimental study, monthly frequency, severity and duration of headache, migraine disability and
clinical side effects in sixty migraineur referred children to Pediatric Neurology Clinic of Shahid Sadoughi Medical
Sciences University, Yazd, Iran from January to June 2013 whom were treated with single dose of 0.3 mg/kg melatonin
for three months, were evaluated.
Results: Thirty two (53.3%) girls and 28(46.7%) boys with mean age of 10.31 ± 2.39 years were evaluated, 38 of whom
(63.3%) had migraine without aura.
Clinical adverse events were seen in 23.3% (N=14) of children including sleepiness in seven, vomiting in four, mild
hypotension in two and constipation in one child. Excessive daytime sleepiness as a serious side effect was seen in three
children which caused the drug use to be stopped.
Monthly frequency, severity and duration of headache reduced from 15.63±7.64 to 7.07±4.42 attacks, from 6.20±1.67 to
3.55± 2.11 scores, and from 2.26±1.34 to 1.11±0.55 hours, respectively. Pediatric Migraine Disability Assessment score
decreased from 31.72 ±8.82 to 17.78 ±10.64. (All p < 0.05).
Conclusion: Melatonin might be considered as an effective and without life-threatening side effects drug in prophylaxis of
migraine in children.