Serum Sodium Changes and Adverse Effect Profile of Carbamazepine Versus Oxcarbazepine in Pediatric Focal Epilepsy: A Randomized Comparative Study

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Background: Carbamazepine and oxcarbazepine are commonly used antiseizure medications for pediatric focal epilepsy. Both drugs may alter serum sodium levels and cause adverse effects, but comparative pediatric data, particularly from South Asian settings, remain limited. Objective: To compare serum sodium changes and adverse-effect profiles of carbamazepine and oxcarbazepine in children with focal epilepsy. Methods: This prospective, single-center, randomized comparative study was conducted in the Department of Paediatric Neurology, National Institute of Neurosciences and Hospital, Dhaka, from January 2020 to June 2020. Children aged 1 to 15 years with newly diagnosed focal epilepsy were randomized to receive either carbamazepine or oxcarbazepine. Serum sodium levels were measured at baseline, 1 month, 3 months, and 6 months after treatment initiation. Development of hyponatremia, defined as serum sodium ≤135 mEq/L, and adverse effects were assessed during follow-up. Data from 86 children were analyzed, including 42 in the carbamazepine group and 44 in the oxcarbazepine group. Results: Baseline characteristics were comparable between groups. Mean serum sodium did not differ significantly at baseline, 136.73 ± 1.66 mmol/L with carbamazepine versus 136.09 ± 2.54 mmol/L with oxcarbazepine, P = .158, or at 1 month, P = .845. At 3 months, serum sodium was significantly lower in the oxcarbazepine group, 137.15 ± 2.49 versus 138.22 ± 2.24 mmol/L, P = .036. This difference persisted at 6 months, 137.56 ± 2.54 versus 138.95 ± 2.20 mmol/L, P = .006. Hyponatremia at 6 months occurred in 15.9% of oxcarbazepine-treated children and 4.7% of carbamazepine-treated children, P = .079. Any adverse reaction occurred in 43.1% and 33.3% of the oxcarbazepine and carbamazepine groups, respectively, P = .382. Anorexia was significantly more frequent with oxcarbazepine, 22.7% versus 0.0%, P = .001. No treatment-related death or hospitalization occurred. Conclusion: Oxcarbazepine was associated with lower mean serum sodium than carbamazepine during follow-up, although categorical hyponatremia did not differ significantly. Both drugs were generally tolerated, but serum sodium and adverse-effect monitoring remain important during pediatric focal epilepsy treatment.

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