Administration in Efficacy of Melatonin Reducing Headaches in Children With Migraines and Sleep Disorders: A Randomized Clinical Trial Study

OBJECTIVES: Migraine headache after tension headache is the most common primary headache in children, and sleep disorders can aggravate the symptoms. Melatonin has been proposed in some studies for prophylaxis of migraine headaches. This study aimed to evaluate melatonin’s effect on migraine symptoms in children with migraine headaches and sleep disorders. MATERIALS & METHODS: In this randomized clinical trial study, all 30 children aged 5 to 15 years with migraine headaches and sleep disorders were referred to the Pediatric Neurology Clinic and enrolled. Patients were randomly divided into two equal groups; the intervention group was treated with melatonin (3 mg daily) and propranolol (1 mg/kg daily), and the control group was treated with propranolol alone (1 mg/kg daily). The severity of the migraine headaches was assessed with PEDMIDAS and a five-point Likert scale. The children’s sleep habits questionnaire (CSHQ) assessed children’s sleep disorders. The ANOVA and linear regression methods were used to analyze and compare the findings between the groups. RESULTS: Out of 30 children participating in the study, 9 were girls, and 21 were boys. The number of daily headaches one month (P = 0.02) and four months (P = 0.03) after treatment was significantly lower in the melatonin group compared to the control group. Regarding sleep quality, there was no significant difference between the two groups. CONCLUSION: Melatonin and propranolol could better alleviate migraine headaches than propranolol alone in children.