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Clinical Effectiveness of Levetiracetam Compared to Fosphenytoin in the Treatment of Benzodiazepine Refractory Convulsive Status Epilepticus

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Abstract

Objectives

To determine whether levetiracetam is an alternative to fosphenytoin to control Benzodiazepine Refractory Status Epilepticus (BRSE) in pediatric population and also to compare the acute drug related side-effects and ventilation requirement among the both arms of anti-epileptic drug therapy.

Methods

All consecutive children admitted with BRSE were randomized to group A, who received fosphenytoin at 20 mg/kg phenytoin equivalents (PE) dose and group B who received levetiracetam at 40 mg/kg over 10 min. Time to terminate seizure (response latency) was measured. If seizure remained refractory after 20 min of test drug administration, appropriate drug escalation was made according to pediatrician’s discretion. All primary and secondary outcome measures were compared between the two therapeutic groups.

Results

Of 61 children enrolled over 18 mo period, 29 (47.5%) were randomized to group A and 32 (52.5%) were randomized to Group B. Baseline characteristics were comparable between the two groups. Among 61 children, 58(98%) required Pediatric Intensive Care Unit (PICU) admission and among those 5(8.2%) children required mechanical ventilation. Duration of PICU stay, hospital stay, the response latency and seizure recurrence were compared between both groups. Significant number of children received additional anti-epileptic drugs (AEDs) in fosphenytoin group [9/29(31%)] compared to levetiracetam group [2/32(7%)] to control seizure.

Conclusions

Levetiracetam may be an effective alternative to fosphenytoin in management of BRSE in children but multicentric trials with large sample size are needed to substantiate this observation.

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Acknowledgements

The authors would like to acknowledge the research staff nurse in Mehta Pediatric ICU. They are grateful to Academy of Pediatric Critical Care (APCC) Scientific Committee Members for manuscript review and providing critical inputs in finalizing the manuscript.

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Authors and Affiliations

  1. Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India

    Sricharantheja Nalisetty, Balaji Sridharan, Vimalraj Vijayakumar & Thangavelu Sangaralingam

  2. Advanced Pediatric Critical Care Center, Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, 600031, India

    Sasidaran Kandasamy

  3. Department of Research & Academics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India

    Nedunchelian Krishnamoorthi

Authors
  1. Sricharantheja Nalisetty
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  2. Sasidaran Kandasamy
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  4. Vimalraj Vijayakumar
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  5. Thangavelu Sangaralingam
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Contributions

SN: Protocol preparation, Subject recruitment, analysis and manuscript writing; SK: Scientific concept, protocol finalization, data interpretation and analysis, manuscript finalization; NK: Research methodology, statistical assistance and supervising the randomization process; BS: Assisted in manuscript writing, proof reading, data verification and finalizing the results; VV: Assisted in manuscript writing, proof reading and data analysis; TS: Protocol finalization, ensuring subject enrollment and study supervision. SK is the guarantor for this paper.

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Correspondence to Sasidaran Kandasamy.

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Nalisetty, S., Kandasamy, S., Sridharan, B. et al. Clinical Effectiveness of Levetiracetam Compared to Fosphenytoin in the Treatment of Benzodiazepine Refractory Convulsive Status Epilepticus. Indian J Pediatr 87, 512–519 (2020). https://doi.org/10.1007/s12098-020-03221-2

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  • DOI: https://doi.org/10.1007/s12098-020-03221-2

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