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Trial registered on ANZCTR


Registration number
ACTRN12624001326583
Ethics application status
Approved
Date submitted
21/09/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of levetiracetam versus phenytoin in children with convulsive status epilepticus, Single blinded Randomized controlled trial
Scientific title
Is intravenous (IV) levetiracetam or IV phenytoin better to terminate seizures when used as a second line treatment for the emergency management of convulsive status epilepticus (CSE) in children.
Secondary ID [1] 313025 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Status epilepticus 335244 0
Condition category
Condition code
Neurological 331798 331798 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to levetiracetam group will receive 40 mg/kg intravenous levetiracetam infusion over 5 min (maximum 2.5g, diluted with 0·9% sodium chloride) and emergency doctor attending that patient will document the prescribed infusion in patient file and monitor the clinical signs for cessation of seizures.
Intervention code [1] 329574 0
Treatment: Drugs
Comparator / control treatment
Participants assigned to phenytoin group will receive 20 mg/kg intravenous infusion over 20 min (maximum dose of 2g, diluted with 0·9% sodium chloride) and emergency doctor attending that patient will document the prescribed infusion in patient file and monitor the clinical signs for cessation of seizures.
Control group
Active

Outcomes
Primary outcome [1] 339436 0
clinical cessation of seizures 15 minutes after completion of infusion of drug in trial group. A clinically apparent seizure cessation will be noted and is defined as termination of focal or generalized tonic clonic movements, nystagmoid or rhythmic eye movements, or generalized or segmental myoclonus
Timepoint [1] 339436 0
seizure cessation will be analyzed after infusion completion. infusion time is about 10 min for the levetiracetam group and 25 minutes for phenytoin group.
Secondary outcome [1] 439976 0
Presence or absence of seizures 30 minutes after the trial drug administration.
Timepoint [1] 439976 0
30 minutes after the completion of infusion in levetiracetam group and 30 minutes after completion of phenytoin infusion.

Eligibility
Key inclusion criteria
: children between age of 2 months to 15 years presenting with convulsive status epilepticus and having received two doses of benzodiazepines as first line anticonvulsant.
Minimum age
2 Months
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who received second line anticonvulsants already or become seizure free after first two doses of benzodiazepines will be excluded. Children with chronic liver disease or kidney disease or any metabolic diseases, causing derangements in blood glucose levels or electrolytes derangements. Children with head trauma will also be excluded. Children with any history of allergy to phenytoin or levetiracetam will also be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
: By using computer generated sequence, a list of randomized integers will be made by a separate person assigned this task.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS Version-27 will be used for data analysis. For continuous variables, descriptive analyses will be presented as mean and standard deviation. For the categorical variables, the descriptive analysis will be presented as percentages. A chi-square test will be used to assess the group differences between categorical variables and get P-value. The independent variable is the groups and dependent variable is presence or absence of seizures at time points specified above. (levetiracetam in the experimental/intervention group and phenytoin as the control group). The intention to treat method will be used to assess the effectiveness of the intervention treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
134
Accrual to date
Final
Recruitment outside Australia
Country [1] 26570 0
Pakistan
State/province [1] 26570 0
khyberpakhtunkhwa

Funding & Sponsors
Funding source category [1] 317466 0
Self funded/Unfunded
Name [1] 317466 0
Country [1] 317466 0
Primary sponsor type
Individual
Name
Dr Hina Parvaiz- Medical Teaching Institute Lady Reading Hospital Peshawar
Address
Country
Pakistan
Secondary sponsor category [1] 319755 0
None
Name [1] 319755 0
Address [1] 319755 0
Country [1] 319755 0
Other collaborator category [1] 283213 0
Hospital
Name [1] 283213 0
Medical Teaching Institute Lady Reading Hospital Peshawar
Address [1] 283213 0
Country [1] 283213 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316180 0
Institutional Review Board
Ethics committee address [1] 316180 0
Lady Reading Hospital Peshawar
Ethics committee country [1] 316180 0
Pakistan
Date submitted for ethics approval [1] 316180 0
10/09/2024
Approval date [1] 316180 0
20/09/2024
Ethics approval number [1] 316180 0
Ref:No.351/LRH/MTI

Summary
Brief summary
Our study is Randomized Controlled trial and it aims to collect evidence regarding superiority of levetiracetam over phenytoin as a second line drug used in management of status epilepticus in children. This will help in development of future guidelines and amendments in existing protocols regarding management of status epilepticus .Outcome will be measured as presence or absence of seizures at 15 minutes and 30 minutes time points after completion of infusion of each drug.
Trial website
nil
Trial related presentations / publications
Public notes
nil

Contacts
Principal investigator
Name 137050 0
Miss Hina Parvaiz
Address 137050 0
Medical Teaching Institute Lady Reading Hospital Soekarno Rd, PTCL Colony, Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
Country 137050 0
Pakistan
Phone 137050 0
+923119913188
Fax 137050 0
Email 137050 0
[email protected]
Contact person for public queries
Name 137051 0
Amir Muhammad
Address 137051 0
MTI Lady Reading Hospital Soekarno Rd, PTCL Colony, Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
Country 137051 0
Pakistan
Phone 137051 0
+923125098679
Fax 137051 0
Email 137051 0
[email protected]
Contact person for scientific queries
Name 137052 0
Hina Parvaiz
Address 137052 0
Medical Teaching Institute Lady Reading Hospital Soekarno Rd, PTCL Colony, Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
Country 137052 0
Pakistan
Phone 137052 0
+923119913188
Fax 137052 0
Email 137052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
will decide later


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.