Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures

T

Tanta University

Status and phase

Completed
Phase 4

Conditions

Febrile Seizures

Treatments

Drug: oral diazepam
Drug: oral melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT03631901
TU2017

Details and patient eligibility

About

To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

Full description

To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.

Enrollment

60 patients

Sex

All

Ages

6 months to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children aged 6 months to 5 yrs .
  • Simple febrile seizures

Exclusion criteria

  • Complex febrile seizures
  • Child with history of neonatal seizure.
  • Afebrile seizures.
  • History of anticonvulsive therapy.
  • Children suffering from epilepsy.
  • Children with abnormal EEG.
  • Children with abnormal neurological examination.
  • Positive family history of epilepsy.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Melatonin
Active Comparator group
Description:
melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.
Treatment:
Drug: oral melatonin
Diazepam
Active Comparator group
Description:
oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.
Treatment:
Drug: oral diazepam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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