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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631901
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Amira Hamed Darwish, Tanta University

Study Description
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Brief Summary:
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

Condition or disease Intervention/treatment Phase
Febrile Seizures Drug: oral melatonin Drug: oral diazepam Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Seizures

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Melatonin
melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.
 Drug: oral melatonin
Both melatonin and diazepam were given only during the febrile illness.
Active Comparator: Diazepam
oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.
 Drug: oral diazepam
Both melatonin and diazepam were given only during the febrile illness.


Outcome Measures
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Primary Outcome Measures :
  1. recurrence of febrile seizures during febrile illness [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. side effect of medications reported in children [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631901


Locations
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Egypt
Tanta University, Faculty of Medicine
Tanta, Egypt
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Amira Darwish Tanta University Hospital
More Information
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Responsible Party: Amira Hamed Darwish, Professor of pediatrics and Principal Investigator, Tanta University
ClinicalTrials.gov Identifier: NCT03631901    
Other Study ID Numbers: TU2017
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amira Hamed Darwish, Tanta University:
Melatonin
Diazepam
recurrence
prophylaxis
Febrile convulsions
Additional relevant MeSH terms:
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Seizures
Seizures, Febrile
Fever
Neurologic Manifestations
Nervous System Diseases
Body Temperature Changes
Diazepam
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Adjuvants, Anesthesia
Anticonvulsants
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents