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Safety and efficacy of melatonin in pediatric migraine prophylaxis

Razieh Fallah, Fatemeh F Shoroki, Farzad Ferdosian1

  • 1Shahid Sadoughi University of Medical Sciences, Yazd, Iran. ferdosianfarzad@yahoo.com.

Current Drug Safety
|June 10, 2014
PubMed

Insights

Melatonin effectively reduced migraine frequency, severity, and duration in children. This study suggests melatonin as a safe option for pediatric migraine prevention, with manageable side effects.

Area of Science:

  • Pediatric Neurology
  • Pharmacology
  • Clinical Trials

Background:

  • Migraine is a common neurological disorder in children, often leading to disabling headaches.
  • Currently, no drugs are FDA-approved for preventive migraine therapy in pediatric populations.
  • Frequent or disabling headaches necessitate preventive treatment in children.

Purpose of the Study:

  • To investigate the safety and efficacy of melatonin for pediatric migraine prophylaxis.
  • To evaluate melatonin's impact on headache frequency, severity, and duration in children.
  • To assess clinical side effects associated with melatonin use in pediatric migraine patients.

Main Methods:

  • A quasi-experimental study involving sixty children with migraine.
  • Treatment with a single dose of 0.3 mg/kg melatonin for three months.
  • Evaluation of monthly headache frequency, severity, duration, and migraine disability.

Main Results:

  • Melatonin significantly reduced monthly headache frequency (15.63 to 7.07 attacks), severity (6.20 to 3.55 scores), and duration (2.26 to 1.11 hours).
  • Pediatric Migraine Disability Assessment scores decreased significantly (31.72 to 17.78).
  • Adverse events occurred in 23.3% of children, including sleepiness, vomiting, mild hypotension, and constipation; serious side effects leading to discontinuation were rare.

Conclusions:

  • Melatonin demonstrates efficacy in the prophylaxis of migraine in children.
  • Melatonin appears to be a safe option for pediatric migraine prevention.
  • The drug is associated with manageable, non-life-threatening side effects.
Abstract

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