Finding a low-risk and low-complication solution to reduce seizures following hyperthermia
Design
A clinical trial with two parallel groups, randomized, no blinding, on 100 sick children
Settings and conduct
This study is conducted on at least 100 children with febrile seizures (F.C.) in the age range of 6 to 60 months and who have indications for anticonvulsant treatment in Heshmatieh Sabzevar Hospital. In this study, children were randomly assigned to two groups under oral treatment with phenobarbital and the other group was treated with levetiracetam using a random number table. According to the entry criteria, people from both groups are initially tested to check blood cells, coagulation tests, and liver tests. Medical treatment begins and after the passage of at least 5 half-lives of the drug (about 15 days) from the start of the treatment, the serum concentration of the drug is measured by HPLC method. And the tests are repeated upon arrival and brain scans(EEG) are taken from patients to rule out epileptic syndromes.Finally, according to the design variables of presence or absence, the amount and intervals of seizures are examined as a result.
Participants/Inclusion and exclusion criteria
Willingness to participate in the study
Convulsions followed by fever
No history of head injury
No history of infectious diseases in the central nervous system
Not suffering from diabetes and taking medications for certain diseases
Intervention groups
The intervention group of children suffering from febrile convulsions, which are divided into two groups. Phenobarbital drug is given to one group and levetiracetam to the other group And after 5 half-lives from the start of the drug, the serum level of the drug is measured.
Main outcome variables
Phenobarbital/ levetiracetam group. EEG. Age. Sex. Family history. History of seizures. Type of fever and convulsions. Intervals between seizures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221105056406N1
Registration date:2022-11-26, 1401/09/05
Registration timing:registered_while_recruiting
Last update:2022-11-26, 1401/09/05
Update count:0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Mahsa Aliakbari sani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 5355
Email address
maliakbari745@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-16, 1401/08/25
Expected recruitment end date
2022-12-26, 1401/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of phenobarbital and levetiracetam in children with febrile seizures
Public title
Comparison of phenobarbital and levetiracetam in febrile seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 6 months to 60 months
Convulsions followed by fever
Exclusion criteria:
Unwillingness to participate in the study
History of head trauma
Diseases of the central nervous system
Having diabetes
Suffering from certain diseases
Taking medicines for specific diseases
Age
From 6 months old to 60 months old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was used for randomization. sample allocation in the study was based on a random sequence provided by the statistics consultant(Table of random numbers).The sequence used was double blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Tohidshahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.MEDSAB.REC.1400.011
Health conditions studied
1
Description of health condition studied
Febrile convulsion(F.C)
ICD-10 code
R56.0
ICD-10 code description
Febrile convulsions
Primary outcomes
1
Description
Number of seizures after receiving levetiracetam
Timepoint
14 days after starting the drug
Method of measurement
Questionnaire and questions from the patient's mother
2
Description
The number of seizures after receiving phenobarbital
Timepoint
14 days after starting the drug
Method of measurement
Questionnaire and questions from the patient's mother
3
Description
Intervals between seizures after receiving levetiracetam
Timepoint
14 days after starting the drug
Method of measurement
Questionnaire and questions from the patient's mother
4
Description
Intervals between seizures after receiving phenobarbital
Timepoint
14 days after starting the drug
Method of measurement
Questionnaire and questions from the patient's mother
5
Description
Side effects after taking levetiracetam
Timepoint
14 days after starting the drug
Method of measurement
Questionnaire and questions from the patient's mother
6
Description
Side effects after taking phenobarbital
Timepoint
14 days after starting the drug
Method of measurement
Questionnaire and questions from the patient's mother
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: The intervention method is a group of children aged 6 months to 60 months who have seizures caused by fever and have indications for drug therapy. Phenobarbital drug is given to this group in the amount of 3 to 5 mg per kilogram daily in two divided doses, and after 5 half-lives from the start of the drug (about 15 days), the serum level of the drug is measured by hplc method. And the number of convulsions and the intervals between convulsions and the side effects of the drug are checked before and after taking the drug.
Category
Treatment - Drugs
2
Description
Intervention group: The intervention method is a group of children aged 6 months to 60 months who have seizures caused by fever and have indications for drug therapy. In this drug group, levetiracetam is given at a dosage of 10 to 20 mg per kg twice a day. and after 5 half-lives from the start of the drug (about 15 days), the serum level of the drug is measured by hplc method. And the number of convulsions and the intervals between convulsions and the side effects of the drug are checked before and after taking the drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatieh hospital
Full name of responsible person
Parastoo amiri
Street address
Asad abadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 51 4401 1073
Email
Amiri.parasto@gmail.com
Web page address
http://www.medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Tohidshahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Email
vc.Research@medsab.ac.ir
Web page address
http://www.medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Parastoo Amiri
Position
Statistical consultant
Latest degree
Specialist
Other areas of specialty/work
Public Health
Street address
Tohidshahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Amiri.Parasto@gmail.com
Web page address
http://www.medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Kazem Hasan pour
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Asadabadi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 51 4424 3465
Email
drhassanpour@yahoo.com
Web page address
http://medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Kazem Hassan Pour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Asadabadi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 51 4424 3465
Email
drhassanpour@yahoo.com
Web page address
http://medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available