Comparison Between Efficacy of Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: A Randomized Clinical Trial.
Study Goal
The researchers aimed to compare the efficacy and safety of oral melatonin versus oral diazepam in preventing recurrent simple febrile seizures in children.
Results Summary
Melatonin reduced febrile seizure recurrence to 17%, compared to 37% with diazepam, though the difference was not statistically significant. Adverse effects were less frequent with melatonin (13.3%) than diazepam (23.3%), with no serious side effects reported for melatonin.
Population
Children aged six to 50 months with recurrent simple febrile seizures.
Effective Dosage
0.3 mg/kg every 8 hours.
Duration
Administered during febrile illness for 48 to 72 hours, with follow-up for six months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
oral melatonin | decrease | recurrence of febrile seizures | children aged six to 50 months with recurrent simple febrile seizures | - | reduced recurrence of febrile seizures | #1 |
oral diazepam | decrease | recurrence of febrile seizures | children aged six to 50 months with recurrent simple febrile seizures | - | reduced recurrence of febrile seizures | #2 |
oral melatonin | decrease | recurrence of febrile seizures | children aged six to 50 months with recurrent simple febrile seizures | 17% (5/30) | recurrence rate | #3 |
oral diazepam | decrease | recurrence of febrile seizures | children aged six to 50 months with recurrent simple febrile seizures | 37% (11/30) | recurrence rate | #4 |
oral melatonin | increase | occurrence of adverse effect | children aged six to 50 months with recurrent simple febrile seizures | 13.3% | adverse effects reported | #5 |
oral diazepam | increase | occurrence of adverse effect | children aged six to 50 months with recurrent simple febrile seizures | 23.3% | adverse effects reported | #6 |
oral melatonin | no change | serious side effects | children aged six to 50 months with recurrent simple febrile seizures | No | serious side effects reported | #7 |
oral diazepam | increase | side effects | children aged six to 50 months with recurrent simple febrile seizures | Sedation and dizziness | main side effects reported | #8 |
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.