Mohammad Sami Barghout1, Azza Kamal Al-Shahawy2, Doaa Mohamed El Amrousy3, Amira Hamed Darwish4. 1. Faculty of Medicine, Department of Pediatrics, Tanta University Hospital, Tanta University, Tanta, Egypt. 2. Faculty of Medicine, Department of Pediatrics, Pediatric Neurology Unit, Tanta University Hospital, Tanta University, Tanta, Egypt. 3. Faculty of Medicine, Department of Pediatrics, Pediatric Cardiology Unit, Tanta University Hospital, Tanta University, Tanta, Egypt. 4. Faculty of Medicine, Department of Pediatrics, Pediatric Neurology Unit, Tanta University Hospital, Tanta University, Tanta, Egypt. Electronic address: amira.darwish@med.tanta.edu.eg.
Abstract
OBJECTIVES: We evaluated the efficacy and safety of oral melatonin compared with oral diazepam for prevention of recurrent simple febrile seizures. METHODS: This prospective randomized clinical trial included 60 children aged six to 50 months with recurrent simple febrile seizures who attended the pediatric neurology clinic in Tanta University Hospital. Children were randomly allocated into two groups: the first group (30 children) received oral melatonin 0.3 mg/kg/8 hours, whereas the other group (30 children) received oral diazepam 1 mg/kg/day divided into three doses. Both melatonin and diazepam were given only during the febrile illness, started at the onset of the fever for 48 to 72 hours. Patients were followed up for six months. The primary outcome was recurrence of febrile seizures and the secondary outcome was occurrence of adverse effect related to melatonin or diazepam. RESULTS: The recurrence rate of febrile seizures was 17% (5/30) in the melatonin group and 37% (11/30) in the diazepam group. There was no significant difference between the two groups (P = 0.08) (95% confidence interval -0.025 to 0.42). Both melatonin and diazepam have significantly reduced recurrence of febrile seizures (P < 0.001). Adverse effects were reported in 13.3% and 23.3% of the children taking melatonin and diazepam, respectively. No serious side effects were reported with melatonin use. Sedation and dizziness were the main side effects reported in children receiving oral diazepam. CONCLUSIONS: Our data suggest that melatonin, administered at the onset of a febrile illness, may effectively reduce the likelihood of recurrent simple febrile seizures. No serious side effects were encountered.
RCT Entities:
OBJECTIVES: We evaluated the efficacy and safety of oral melatonin compared with oral diazepam for prevention of recurrent simple febrile seizures. METHODS: This prospective randomized clinical trial included 60 children aged six to 50 months with recurrent simple febrile seizures who attended the pediatric neurology clinic in Tanta University Hospital. Children were randomly allocated into two groups: the first group (30 children) received oral melatonin 0.3 mg/kg/8 hours, whereas the other group (30 children) received oral diazepam 1 mg/kg/day divided into three doses. Both melatonin and diazepam were given only during the febrile illness, started at the onset of the fever for 48 to 72 hours. Patients were followed up for six months. The primary outcome was recurrence of febrile seizures and the secondary outcome was occurrence of adverse effect related to melatonin or diazepam. RESULTS: The recurrence rate of febrile seizures was 17% (5/30) in the melatonin group and 37% (11/30) in the diazepam group. There was no significant difference between the two groups (P = 0.08) (95% confidence interval -0.025 to 0.42). Both melatonin and diazepam have significantly reduced recurrence of febrile seizures (P < 0.001). Adverse effects were reported in 13.3% and 23.3% of the children taking melatonin and diazepam, respectively. No serious side effects were reported with melatonin use. Sedation and dizziness were the main side effects reported in children receiving oral diazepam. CONCLUSIONS: Our data suggest that melatonin, administered at the onset of a febrile illness, may effectively reduce the likelihood of recurrent simple febrile seizures. No serious side effects were encountered.