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Completed

NCT Number: NCT03631901

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

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

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Key information

Conditions

Febrile Seizures Disease Attributes Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Seizures Seizures, Febrile Signs and Symptoms

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University, Faculty of Medicine

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral melatonin

Drug

Both melatonin and diazepam were given only during the febrile illness.

oral diazepam

Drug

Both melatonin and diazepam were given only during the febrile illness.

Primary outcomes

  1. recurrence of febrile seizures during febrile illness

    Time frame: 6 months

Secondary outcomes

  1. side effect of medications reported in children

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2018
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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