Protocol summary

Summary
The aim of this study is to compare the effectiveness of 3 interventions for prevention of recurrence in early stages of febrile seizures in children under 5 years. This study will determine whether these interventions or no intervention are different during the course of the disease? In addition, the mentioned interventions are accompanied with what kind of side effects. In this study all of the patients who are qualified to include in the research will be included gradually in the study. In based on block randomization. Group 1: the patients who won t receive any drug of seizure. Group 2: the patients will receive phenobarbital stat 10 mg/kg IM at the beginning of the admit. Group 3: the patients will receive phenobarbital stat 10mg/kg IM at the beginning of the admit and then 2.5 mg/kg/dose IM every 12 hours and this process will be followed by receiving tab phenobarbital with the same dose after the beginning of oral nutrition until cut fever. Group 4: the patients will receive tab diazepam 0/3 mg/kg in every 8 hours and this process will be continued until cut fever. If one of the mentioned group will strike recurrent seizure during the period of admit in the hospital regardless of the above groups they will receive amp phenobarbital 10 mg/kg IM STAT and 2/5 mg/kg/dose every 12 hours and this process will be followed by receiving tab phenobarbital with the same dose after the beginning of oral nutrition. the patient information will be recorded as recurrent seizure.all of the patients will be checked for the reason of fever.the LP will be accomplished according to circumstance and regarding to the available indication about the reason of the fever.for all of the patients if the temperature of the axillary will be more than 37/5 C. According to circumstance the syrup acetaminophen 10-15 mg/kg oral will be prescribed .regarding to the patient conditions the patient will be requested to do routine tests.in the cases such as complex febrile seizure or the history of developmental delay or neurological exam the patients are requested to do brain CT scan or brain MRI. All of the information including of the personal information family history the seizure caracteristic and recurrency of seizure will be recorded in the information form and the results will be evaluated using SPSS 16 software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016080229171N1
Registration date: 2017-02-17, 1395/11/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-17, 1395/11/29
Registrant information
Name
Afshin Fayazi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1446 3975
Email address
a.fayazi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
no
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of diazepam and phenobarbital for prevention of recurrent seizure In early stages of febrile convalsion in children 6 month to 5 years
Public title
Effectiveness of diazepam and phenobarbital in prevention of recurrent febrile seizure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:First Simple febrile convulsion; complex febrile convulsion(maximum two); reccurent febrile convulsion(maximum one); temperature of more than 37/5 axillary during of seizure; no history of seizure without having fever; lack of the previous neurodevelopmental delay; age of more than 6 months to 5 years. exclusion criteria: status epilepticus; electrolyte imbalance; serial seizure before referring to hospital(more than two); abnormality inneuroimaging; drug reaction to phenobarbital(skin rash,stiven janson,TEN), noncooperation; serial seizure more as 2
Age
From 6 months old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
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
Hamedan University Of Medical Sciences
Street address
Ayatollah Kashani Boulvard, Khaje Rashid Crossroad
City
Hamedan
Postal code
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.UMSHA.REC.1395.88

Health conditions studied

1

Description of health condition studied
febrile convulsions
ICD-10 code
R56.0
ICD-10 code description
Febrile Convulsions

Primary outcomes

1

Description
Reccurency of seizure
Timepoint
in admit hospital
Method of measurement
questionar

2

Description
Status Epilepticus
Timepoint
in admit hospital
Method of measurement
Questionar

Secondary outcomes

empty

Intervention groups

1

Description
IN 3 interventions groups, first group amp phenobarbital 10mg/kg stat
Category
Treatment - Drugs

2

Description
No drug in control group
Category
Treatment - Drugs

3

Description
Amp Phenobarbital 10mg/kg stat IM and then 2.5 mg/kg/dose IM every 12 hours to cut fever
Category
Treatment - Drugs

4

Description
Tab Diazepam 0/3 mg/kg in 8 hour to cut fever
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Reihane Eslamian
Street address
Besat hospital, Ayatollah Motahari Boulvard, Resalat Square
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Hashemian Farnaz
Street address
Ayatollah kashani Boulvard,Khaje Rashid Crossroad
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Afshin Fayazi
Position
Pediatrics Neurologist
Other areas of specialty/work
Street address
Hospital Besat, Ayatollah Motahary Boulvard, Resalat Square
City
Hamedan
Postal code
Phone
+98 914 321 0149
Fax
Email
a.fayazi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Afshin Fayazi
Position
Pediatrics Nerologist
Other areas of specialty/work
Street address
Ayatollah Motahary Boulvard, Resalat Square, Besat Hospital
City
Hamedan
Postal code
Phone
+98 914 321 0149
Fax
Email
a.fayazi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Reihane Eslamian
Position
Pediatric Assistent
Other areas of specialty/work
Street address
Besat Hospital, Ayatollah Motahary Boulvard, Resalat Square
City
Hamedan
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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