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Effectiveness and Safety of Nitrazepam in Children with Resistant West Syndrome

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Abstract

Objectives

To study the effectiveness, tolerability, and safety of oral nitrazepam in children with resistant West syndrome (WS).

Methods

This prospective observational study was conducted at a tertiary care hospital in North India from January 2019 to October 2020. Children with WS resistant to standard therapy were enrolled within 7 d of initiation of nitrazepam and prospectively followed-up for cessation of spasms and adverse events.

Results

Forty-one children with resistant WS initiated on nitrazepam therapy were evaluated. The median age at onset of spasms was 6 mo (Q1, Q3: 4, 8). There was a preponderance of male gender (71%) and structural causes (78%). More than half of the enrolled children had failed four or more antiseizure medications (ASM) for epileptic spasms. The study participants had a long lead-time-to-treatment (LTTT) for the initial standard therapy (median: 2 mo; Q1, Q3: 1, 5) and nitrazepam (median: 11 mo; Q1, Q3: 8, 16). Nitrazepam was instituted as monotherapy in 7 (17%) children and as an adjunct in the rest. Twenty-one (51%) children achieved persistent cessation of epileptic spasms. However, the electroclinical response was observed in 17 (42%) children. Drowsiness, sialorrhea, and decreased appetite were the most commonly observed adverse events. Most adverse events were mild to moderate in severity and did not require dose reduction or change of medication. There was no significant difference between the responders and nonresponders in terms of LTTT, age at onset, or etiology.

Conclusions

Nitrazepam is a safe and feasible treatment alternative in children with resistant WS resulting in persistent cessation of spasms and electroclinical response in nearly half of patients.

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Acknowledgements

The authors thank the families of all children with West syndrome who participated in the study.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Advanced Pediatrics Centre, PGIMER, Chandigarh, India

    Sayeeda Zahan

  2. Pediatric Neurology Unit, Department of Pediatrics, Advanced Pediatrics Centre, PGIMER, Chandigarh, India

    Jitendra Kumar Sahu, Priyanka Madaan, Renu Suthar, Arushi Gahlot Saini, Lokesh Saini & Naveen Sankhyan

  3. Department of Pharmacology, PGIMER, Chandigarh, India

    Smita Pattanaik

  4. Department of Neurology, All India Institute of Medical Sciences, New Delhi, India

    Amit Kumar

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  1. Sayeeda Zahan
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  2. Jitendra Kumar Sahu
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  9. Naveen Sankhyan
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Contributions

SZ, JKS: Planning and conduct of the study, data collection, data analysis, literature search, and preparation of the initial draft; PM: EEG interpretation, data collection, data interpretation, preparation of the initial draft and critical review of manuscript; RS, SP, AGS, LS, NS: Planning and conduct of the study, data collection, data interpretation and critical review of the manuscript; AK: Data analysis, literature search, and critical review of the manuscript; SZ, AK: Statistical analysis. All authors approved the final version of the manuscript to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. JKS is the guarantor of this paper.

Corresponding author

Correspondence to Jitendra Kumar Sahu.

Ethics declarations

Ethical Committee Approval

Was obtained from IEC at PGIMER, Chandigarh vide INT/IEC/2019/000245 dated 11/02/2019.

Informed Consent

Was obtained from parents of each subject before enrolment.

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Zahan, S., Sahu, J.K., Madaan, P. et al. Effectiveness and Safety of Nitrazepam in Children with Resistant West Syndrome. Indian J Pediatr 89, 37–44 (2022). https://doi.org/10.1007/s12098-021-03823-4

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  • DOI: https://doi.org/10.1007/s12098-021-03823-4

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