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Current Drug Safety
ISSN (Print): 1574-8863
ISSN (Online): 2212-3911
Epub Full Text Article
DOI: 10.2174/1574886309666140605114614      Price:  $95









Safety and Efficacy of Melatonin in Pediatric Migraine Prophylaxis

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Author(s): Razieh Fallah, Fatemeh Fazeli Shoroki and Farzad Ferdosian
Abstract:
Objective: Preventive therapy in migraine must be started in children with frequent or disabling headaches and up to now, no drugs have been approved for migraine preventive therapy in children. 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 of sixty migraineurs children whom were referred to Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from January to June 2013 and 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, 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

Keywords:
Child, headache, melatonin, migraine, prophylaxis
Affiliation:
Shahid Sadoughi Hospital , Ave - Sina Blvd, Shahid Ghandi Blvd, Yazd, I.R.Iran