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CTRI Number  CTRI/2020/12/029566 [Registered on: 04/12/2020] Trial Registered Prospectively
Last Modified On: 13/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   To compare between intravenous Levetiracetam and Intravenous Phenytoin which is better as second Line anticonvulsant in paediatric status Epilepticus  
Scientific Title of Study   Intravenous Levetiracetam versus Intravenous Phenytoin for Second line treatment of Pediatrics Convulsive Status Epilepticus - Open label Randomized Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mamum Kartek 
Designation  Postgraduate-JR Department of Pediatrics  
Affiliation  AIIMS Raipur 
Address  Room no 310 ,Intern hostel Tatiband Aiims Raipur-492099 Phone no. 8098220235
Aiims Raipur Tatiband ,GE Road Chattisgarh 492099 0771-2573777
Raipur
CHHATTISGARH
492099
India 
Phone  8098220235  
Fax    
Email  mamumkartek47@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mamum Kartek 
Designation  Postgraduate-JR Department of Pediatrics  
Affiliation  AIIMS Raipur 
Address  Intern hostel Tatiband Aiims Raipur-492099 Phone no. 8098220235
Aiims Raipur Tatiband ,GE Road Chattisgarh 492099 0771-2573777
Raipur
CHHATTISGARH
492099
India 
Phone  8098220235  
Fax    
Email  mamumkartek47@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manas Ranjan Sahoo 
Designation  Associate Professor,Department of Pediatrics  
Affiliation  AIIMS Raipur 
Address  Aiims Raipur Tatiband Chattisgarh-492099 7893230151
Aiims Raipur G E Road Tatiband Chhattisgarh -492099
Raipur
CHHATTISGARH
492099
India 
Phone  7893230151  
Fax    
Email  drmrsahoo@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur 
 
Primary Sponsor  
Name  Mamum Kartek  
Address  Post graduate JR Department of Pediatrics AIIMS Raipur Intern hostel Tatiband Aiims 492099 
Type of Sponsor  Other [Principal Investigator ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mamum Kartek   AIIMS Raipur ( Pediatrics Emergency)  Aiims Raipur GE Road ,Tatiband Raipur -492099
Raipur
CHHATTISGARH 		 8098220235

mamumkartek47@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Aiims Raipur( Chhattisgarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levetiracetam   Levetiracetam group will receive 40 mg/kg intravenously diluted with sodium chloride 0.9% in 1:1 ratio and give over 5 minutes . 
Comparator Agent  Phenytoin  Phenytoin group will receive 20mg/kg intravenously diluted with sodium chloride 0.9% to minimum volume of 20 ml give over 20 minutes  
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Presenting with generalized tonic clinic ,generalized clonic,generalized tonic,generalised myoclonic ,focal tonic or focal clonic seizures
2. Children who had received 2 doses of midazolam
3. Children who had received 2 doses of midazolam for generalized convulsive seizures lasting more than 5 minutes and continued to have persistent or recurrent convulsions in the emergency department at least 5 minutes after the last dose of benzodiazepines
4. Patient on maintenance dose of phenytoin and Levetiracetam with bad compliance  
 
ExclusionCriteria 
Details  1.Age<3 months and >15 years of age .
2. Children presenting with absence seizures or infantile spasms .
3. Convulsive status Epilepticus due to hypocalcemia,hypoglycaemia,hypercalcemia .
4. Patient had received second line Anticonvulsant during the episode of convulsive status epilepticus .
5. Patients with arrhythmia .
6. Patients allergic to Levetiracetam and phenytoin .
7. Patients already on maintenance dose of phenytoin and Levetiracetam with good compliance .
8. Seizure controlled with 2 doses of midazolam .
9. Parents / care providers not giving consent .
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Absence of clinically apparent seizures after 5 minutes of completion of trial drug infusion without additional anticonvulsants medication.  2 years  
 
Secondary Outcome  
Outcome  TimePoints 
Patients requiring further anticonvulsants to manage convulsive status epilepticus,recurrence of seizures, change in cardio respiratory parameter ,need for admission to PICU and any drug related serious adverse reactions .  2 years  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a open label randomized controlled trial to compare the efficacy and safety of intravenous Levetiracetam and phenytoin as second line anticonvulsants drug in aborting seizure in Pediatrics status epilepticus. Randomisation will be done by stratified block randomisation and after randomisation group one will receive Levetiracetam 40mg/kg over 5 minutes and group two will receive phenytoin 20mg/kg over 20 minutes .clinical cessation of seizures is assessed after 5 minutes of completion of trial drug infusion. The maintenance dose of Levetiracetam will be started after 12 hours of loading dose and phenytoin after 24 hours in respective group . If seizure still persists after first dose of Levetiracetam and phenytoin ,then cross over will be done . The maintenance dose of Levetiracetam will be started after 12 hours of loading dose and phenytoin after 24 hours in both the group. If seizure doesn’t abort then clinical decision shall be given to treating clinicians and outcome of the patient will be followed up to exit from the study and analysed as per intention to treat .


 
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