title: Safety and efficacy of melatonin in pediatric migraine prophylaxis.
abstract: 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).
  
  
  CONCLUSIONS
  Melatonin might be considered as an effective and without life-threatening side effects drug in prophylaxis of migraine in children.
authors.forename: Razieh
authors.initials: R
authors.lastname: Fallah
authors.forename: Fatemeh F
authors.initials: FF
authors.lastname: Shoroki
authors.affiliation: Shahid Sadoughi University of Medical Sciences, Yazd, Iran. ferdosianfarzad@yahoo.com.
authors.forename: Farzad
authors.initials: F
authors.lastname: Ferdosian
mesh_terms: D000293:Adolescent; D000975:Antioxidants / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008550:Melatonin / Q000009:adverse effects* / Q000627:therapeutic use*; D008881:Migraine Disorders / Q000517:prevention & control*; D020325:Migraine with Aura / Q000517:prevention & control; D020326:Migraine without Aura / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D008550:Melatonin