Comparing the effectiveness of melatonin and clobazam in the prophylaxis of febrile seizures

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221102056380N1

Enrollment

Registered

2023-08-26

Start date

2020-10-01

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Seizure. Simple febrile convulsions

Interventions

Intervention 1: Intervention group: During the first 48 hours of febrile illness, melatonin at the dose of 0.3 mg/kg is given orally to children every 8 hours. The melatonin tablet contains 3 mg of th

Eligibility

Sex/Gender

All

Age

12 Months to 5 Years

Inclusion criteria

Inclusion criteria: Children aged Twelve months to 5 years It is the patient's second febrile seizure

Exclusion criteria

Exclusion criteria: History of receiving medication for prophylaxis History of epilepsy or other neurological disorders History of developmental delay

Design outcomes

Primary

Measure	Time frame
The recurrence of subsequent attacks of simple febrile seizures. Timepoint: 6 and 12 months after the start of the intervention in children with febrile seizures. Method of measurement: Questions from parents.;Identification of drug side effects. Timepoint: 6 and 12 months after the start of the intervention in children with febrile seizures. Method of measurement: Questions from parents.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNahid Khosroshahi

Tehran University of Medical Sciences

n_khosroshahi@tums.ac.ir+98 21 7301 3000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026