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.


METHODS
Prospective randomised controlled single centre trial.


METHODS
Specialist children's hospital in Dhaka, Bangladesh.


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


METHODS
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.


CONCLUSIONS
There was no excess in behavioural side effects with phenobarbital in children with epilepsy in a country with limited resources. Trial registration NCT00381537.
Banu
Selina H
SH
Child Development and Neurology Unit, Dhaka Shishu (Children's) Hospital, Bangladesh Institute of Child Health, Sher-e-Bangla Nagar, Dhaka 1207, Bangladesh.
Jahan
Moshrat
M
Koli
Umme Kulsum
UK
Ferdousi
Saadia
S
Khan
Naila Z
NZ
Neville
Brian
B
D000293:Adolescent; D000927:Anticonvulsants / Q000009:adverse effects*; D002220:Carbamazepine / Q000009:adverse effects*; D002648:Child; D002653:Child Behavior Disorders / Q000139:chemically induced*; D002675:Child, Preschool; D004311:Double-Blind Method; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010634:Phenobarbital / Q000009:adverse effects*; D011446:Prospective Studies
D000927:Anticonvulsants; D002220:Carbamazepine; D010634:Phenobarbital