Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial.

OBJECTIVE

To compare the behavioural side effects associated with two commonly used antiepilepsy drugs-phenobarbital and carbamazepine-in children in Bangladesh.

DESIGN

Prospective randomised controlled single centre trial.

SETTING

Specialist children's hospital in Dhaka, Bangladesh.

PARTICIPANTS

108 children aged 2-15 with generalised tonic-clonic (n=51) or partial and secondary generalised seizures (n=57).

MAIN OUTCOME MEASURES: Seizure control and behavioural side effects.

RESULTS

91 children were followed up for 12 months. Six required a change of antiepilepsy drug. Side effects were compared in 85 children. In the last quarter of the 12 month follow-up, 71 children were seizure free after one year's treatment. Thirty two in the phenobarbital group and 39 in the carbamazepine group had no seizures in 74 and 102 days after randomisation, respectively. Ten children had increased behavioural problems, which were unacceptable in four (one in the phenobarbital group and three in the carbamazepine group). Independent t tests, however, showed no difference between the two trial drugs.

CONCLUSION

There was no excess in behavioural side effects with phenobarbital in children with epilepsy in a country with limited resources. Trial registration NCT00381537.