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
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