Melatonin Vs. Clobazam for Preventing Recurrent Simple Febrile Seizures: A Randomized Clinical Trial Publisher



Khosroshahi N ; Zareamanat S ; Khayatzadehkakhki S ; Eftekhari K
Source: Acta Medica Iranica Published:2026

Abstract

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). © 2026 Tehran University of Medical Sciences. All rights reserved.