Comparison of clinical efficacy and safety of injectable Levetiracetam versus Phenytoin as second line drug in the management of generalized convulsive status epilepticus in children: An open label randomized control trial
To compare the clinical efficacy and safety of injectable Levetiracetam versus Phenytoin as a second-line drug in the management of generalized convulsive status epilepticus in children.
Design
Parallel open-label randomized control trial.
Settings and conduct
Emergency department, Children’s Hospital and the Institute of Child Health, Multan, Pakistan
Participants/Inclusion and exclusion criteria
Male and Female Patients aged one to 14 years. Patients with generalized convulsive status epilepticus, not responding to two doses of diazepam (0.2 mg/kg) given 5 minutes apart. Parents /guardians of children willing to give Written informed consent.
Children received anticonvulsant treatment other than benzodiazepine for the acute management of CSE. Children on assisted ventilation. Children with CSE secondary to hypertensive encephalopathy, head injury, chronic kidney or liver disease and electrolyte derangement (hypoglycemia, hypocalcemia, hypo/hypernatremia, hypomagnesemia)
Intervention groups
Group A: Levetiracetam 40mg/kg infused in 15 minutes
Group B: Phenytoin 20 mg/kg infused in 30minutes.
Main outcome variables
Efficacy: cessation of seizures within 30 minutes of administration.
Safety: • Respiratory depression • Cardiac depression • Hypotension • Central nervous system (CNS) depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170614034526N2
Registration date:2018-09-26, 1397/07/04
Registration timing:retrospective
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Dr. Sharib Syed Muhammad
Name of organization / entity
Hilton Pharma Pvt Ltd
Country
Pakistan
Phone
(021) 111-123-000 Ext:428
Email address
sharibsyed@hiltonpharma.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-01-27, 1392/11/07
Expected recruitment end date
2018-05-30, 1397/03/09
Actual recruitment start date
2014-01-30, 1392/11/10
Actual recruitment end date
2018-06-20, 1397/03/30
Trial completion date
2018-06-30, 1397/04/09
Scientific title
Comparison of clinical efficacy and safety of injectable Levetiracetam versus Phenytoin as second line drug in the management of generalized convulsive status epilepticus in children: An open label randomized control trial
Public title
Comparison of clinical efficacy and safety of injectable Levetiracetam versus Phenytoin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and Female Patients aged one to 14 years.
Patients with generalized convulsive status epilepticus, not responding to two doses of diazepam (0.2 mg/kg) given 5 minutes apart.
Parents /guardians of children willing to give Written informed consent.
Exclusion criteria:
Children received anticonvulsant treatment other than benzodiazepine for the acute management of CSE.
Children on assisted ventilation
Children with CSE secondary to hypertensive encephalopathy, head injury, chronic kidney or liver disease and electrolyte derangement (hypoglycemia, hypocalcaemia, hypo/hypernatremia, hypomagnesaemia)
Age
From 1 year old to 14 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
650
Actual sample size reached:
600
Randomization (investigator's opinion)
Randomized
Randomization description
Children were divided into two groups by random allocation for the selection of second-line drug. Children received Levetiracetam were assigned as group A (LEV group) and those received phenytoins were assigned as group B (PHT group).
Sealed envelope system was used for randomization. A set of envelopes were prepared, each bearing the name of the drug (Phenytoin and Levetiracetam were written on 300 envelopes each) on it. All envelops were sealed properly and shuffled by a person not involved in the study. These pre-written, drug named sealed envelopes were opened at the time of administration of the second-line drug for the management of CSE.
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
Ethical committee of Children Hospital and institute of Child Health, Multan.
Street address
Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad,
City
Multan
Postal code
60000
Approval date
2014-01-25, 1392/11/05
Ethics committee reference number
CHICH/EC/DR.NUZHAT NOUREEN/25-01-2014/109
Health conditions studied
1
Description of health condition studied
Generalized convulsive status epileptics.
ICD-10 code
G41.8
ICD-10 code description
Other status epilepticus
Primary outcomes
1
Description
Efficacy: cessation of seizures
Timepoint
within 30 minutes of administration
Method of measurement
Visual Inspection
Secondary outcomes
1
Description
Safety: • Respiratory depression • Cardiac depression • Hypotension • Central nervous system (CNS) depression
Timepoint
From administration of study drug till the patient under monitoring for acute condition.
Method of measurement
Monitoring was done by base line arterial blood gases, electrocardiogram, blood pressure and Glasgow coma scale.
Intervention groups
1
Description
Intervention group: Group A: Levetiracetam 40mg/kg infused in 15 minutes
Category
Treatment - Drugs
2
Description
Control group: Group B: Phenytoin 20 mg/kg infused in 30minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Hospital and institute of Child Health
Full name of responsible person
Dr. Nuzhat Noureen
Street address
Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad,
City
Multan
Postal code
60000
Phone
+92 61 9201431
Email
drnuzhatrana@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Children Hospital and institute of Child Health
Full name of responsible person
Dr. Nuzhat Noureen
Street address
Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad,
City
Multan
Postal code
60000
Phone
+92 61 9201431
Email
drnuzhatrana@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Children Hospital and institute of Child Health
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
Children Hospital and institute of Child Health
Full name of responsible person
Dr. Nuzhat Noureen
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad,
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 61 9201431
Email
drnuzhatrana@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children hospital and institute of child health
Full name of responsible person
Dr. Nuzhat Noureen
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad,
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 61 9201431
Email
drnuzhatrana@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
children hospital and institute of child health
Full name of responsible person
Dr. Nuzhat Noureen
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad,
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 61 9201431
Email
drnuzhatrana@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To keep the confidentiality of the study participants, however, data would be made available to the Ethics Committee of the institute upon requirement