N Thilothammal1, K Banu, R S Ratnam. 1. Clinical Epidemiology Unit, Institute of Child Health and Hospital for Children, Madras.
Abstract
OBJECTIVE: To compare the efficacy and side effects of phenobarbitone (PB), phenytoin (PHT) and sodium valproate (SVP) in controlling generalized tonic-clonic convulsions (GTC). DESIGN: Randomized, double blind clinical trial. SETTING:Out-Patients in a tertiary care hospital. PATIENTS: 151 children with GTC, aged 4-12 yrs, from Madras city were enrolled. At the end of 2 yrs, 127 children remained in the study. INTERVENTION: Each child was given one active drug and 2 placebo tablets. Clinical, hematological and biochemical evaluations were done every month. Serum drug levels were assessed periodically. MAIN OUTCOME MEASURES: Recurrence of convulsion and side effects. RESULTS: The proportion of children with recurrence did not differ among the 3 groups. More than one side effect was observed in 16 (32%) children on PB, 20 (40%) children on PHT and 9 (19%) children on SVP and this difference was statistically significant (p < 0.05). Hyperactivity was the major side effect of PB, observed in 22% of children. CONCLUSION: All 3 drugs were equally effective in controlling seizures. Side effects were minimal with SVP followed by PB. Though side effects were more frequent with PHT, most of them disappeared on adjusting drug dosage. Least expensive phenobarbitone may be preferred as the first drug of choice but, only for pre-school children. SVP is advised for school going children.
RCT Entities:
OBJECTIVE: To compare the efficacy and side effects of phenobarbitone (PB), phenytoin (PHT) and sodium valproate (SVP) in controlling generalized tonic-clonic convulsions (GTC). DESIGN: Randomized, double blind clinical trial. SETTING: Out-Patients in a tertiary care hospital. PATIENTS: 151 children with GTC, aged 4-12 yrs, from Madras city were enrolled. At the end of 2 yrs, 127 children remained in the study. INTERVENTION: Each child was given one active drug and 2 placebo tablets. Clinical, hematological and biochemical evaluations were done every month. Serum drug levels were assessed periodically. MAIN OUTCOME MEASURES: Recurrence of convulsion and side effects. RESULTS: The proportion of children with recurrence did not differ among the 3 groups. More than one side effect was observed in 16 (32%) children on PB, 20 (40%) children on PHT and 9 (19%) children on SVP and this difference was statistically significant (p < 0.05). Hyperactivity was the major side effect of PB, observed in 22% of children. CONCLUSION: All 3 drugs were equally effective in controlling seizures. Side effects were minimal with SVP followed by PB. Though side effects were more frequent with PHT, most of them disappeared on adjusting drug dosage. Least expensive phenobarbitone may be preferred as the first drug of choice but, only for pre-school children. SVP is advised for school going children.
Authors: R Idro; K A Musubire; B Byamah Mutamba; H Namusoke; J Muron; C Abbo; R Oriyabuzu; J Ssekyewa; C Okot; D Mwaka; P Ssebadduka; I Makumbi; B Opar; J R Aceng; A K Mbonye Journal: Afr Health Sci Date: 2013-06 Impact factor: 0.927