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Completed

NCT Number: NCT02920060

Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus

This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion. Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus.

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Key information

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

In our study patients were considered to have RSE if children were still having active convulsions despite receiving injection lorazepam intravenously at a dose of 0.1 mg/kg (max 4 mg) at a rate maximum upto 2 mg/min or intravenous diazepam at a dose of 0.2 - 0.3 mg/Kg (maximum 10 mg) slowly or intravenous midazolam at a dose of 0.15 - 0.2 mg/kg(max 5 mg). In case of children with difficult intravenous access buccal/nasal midazolam 0.2 - 0.3 mg/kg (maximum 5 mg) per rectal diazepam 0.5 mg/kg (maximum 10 mg) or intramuscular midazolam 0.2 mg/kg (maximum 5 mg). If seizure continued at 5 minutes, a repeat dose of benzodiazepine was given with same dose. At 10 minutes, if the seizure activity still remains intravenous phenytoin was given at a dose of 20mg/kg(maximum- 1000mg) at a rate of 1mg/kg/minute or intravenous fosphenytoin at 20mg PE/kg (if available) at a rate of 3mg PE/kg/minute.

Patients having seizure activity despite administration of above medications were considered to have RSE. Out of thousands of patients seen in outdoor and emergency ward, 80 patients were diagnosed to have RSE and met the inclusion criteria. After counselling the parents/guardians about the medications and obtaining a written informed consent they were randomized to into two groups : sodium valproate(V) and levetiracetam group(L), using a computer generated randomization chart. Forty patients in group V received intravenous valproic acid in dose of 20 mg/kg as loading dose at a rate of 40 mg/min after dilution with normal saline followed by maintenance dose of 10mg/kg/dose 8 hourly. In group L patients received intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min followed by 20mg/kg/dose 12 hourly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age - 1 year to 16 years
  • Gender - male and female both
  • Refractory generalized convulsive status epilepticus i.e. not responding to any two of the first line drugs

Exclusion criteria

  • Patients with epilepsia partialis continua.
  • Patients with definite history of any allergic reaction to intravenous levetiracetam or intravenous valproate, or any contraindications in giving these drugs.

Treatment and study plan

Intravenous levetiracetam

Drug

intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).

Other names: injection Levera

Sodium Valproate

Drug

intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)

Other names: injection Encorate

Primary outcomes

  1. cessation of convulsions (clinically evident motor activity)

    Time frame: 30 minutes

    clinical cessation of convulsions, vitals monitoring

Secondary outcomes

  1. seizure activity at 24 hours of infusion

    Time frame: 24 hours

    whether clinical convulsive activity cessation or not

  2. seizure recurrence

    Time frame: 24 hours

    average number of seizure recurring after drug infusion within 24 hours

  3. additional number of drugs

    Time frame: 24 hours

    number of additional drugs to control RSE within 24 hours of infusion

  4. time taken to control seizure activity

    Time frame: 24 hours

    time needed to control convulsive activity from infusion time

  5. change in vital parameters after infusing interventional agent

    Time frame: 24 hours

    vital parameters will be recorded every 15 minutes for the first 1 hour after the intervention began and mean value of vital parameters will be compared in two groups

  6. neurological outcome and seizure control

    Time frame: 1 month

    to look for any neurological deficit or behavioural abnormality and seizure control at one month of follow-up

Sponsors and collaborators

Lead sponsor

Banaras Hindu University

Other

Collaborators

  • Institute of Medical Sciences of the Banaras Hindu University, India

Registry information

Official study title

Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus : An Open Randomized Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2016
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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