Tehran University of Medical Sciences Acta Medica Iranica 0044-6025 0 0 2026 04 21 11335 11335 Nahideh Khosroshahi Department of Pediatric Neurology, Deviation of Pediatric Neurology, Bahrami Children’s Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. Salar Zare-Amanat Deviation of Pediatric Neurology, Bahrami Children’s Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. Simin Khayatzadeh-kakhki Department of Pediatric Neurology, Deviation of Pediatric Neurology, Bahrami Children’s Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. Kambiz Eftekhari Department of Pediatric, Pediatric Gastroenterology and Hapatology Research Center, Bahrami Children's Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran 2024 11 02 2025 08 04 Febrile seizures are the most common neurologic disorder in infants and young children. Febrile seizures generally have a good prognosis, but approximately one-third of patients may experience a second attack. This study was conducted to assess the effectiveness of melatonin in preventing the recurrence of subsequent seizures. In this prospective randomized clinical trial study, 60 children with febrile seizures were enrolled in two groups of 30. Clobazam was administered to the control group, while melatonin was given to the intervention group for prophylaxis. Over a 12-month telephone follow-up, the number of febrile illnesses and seizure attacks, as well as drug side effects, was recorded of the 60 children included in this study, 56.7% were boys. The mean age of the participants was 30.22±11.69 months. Seven patients experienced febrile seizures after receiving prophylactic medication, including three patients in the melatonin group and four in the clobazam group. This difference was not statistically significant (P=1.00). Additionally, only two patients in the control group experienced sleepiness. Melatonin may be effective in preventing recurrent febrile seizure episodes without any serious side effects. Iranian Registry of Clinical Trial (IRCT20221102056380N1). https://acta.tums.ac.ir/index.php/acta/article/view/11335 https://acta.tums.ac.ir/index.php/acta/article/download/11335/6030