Single daily dose of digoxin for maintenance therapy of infants and children with cardiac disease: is it reliable?

Between July 1990 and September 1991, 30 infants and children, most of whom had a congenital heart defect and who had been treated at least during the previous 20 days by two daily doses of digoxin and were in a stable clinical condition, were selected at random. A maintenance dose of digoxin was administered at 24-h intervals for 7 days in the study group (n = 15); no change was made in the 12-h dosage interval in the control group (n = 15). When the serum digoxin concentrations were compared, no significant difference was found between pre- and poststudy values in the study group (1.0 +/- 0.6 and 0.8 +/- 0.3 ng/ml, respectively) or between the control and study groups (0.9 +/- 0.6 and 0.8 +/- 0.3 ng/ml, respectively) in terms of trough serum digoxin concentrations. Although the peak serum concentrations in the study group were increased significantly (2.3 +/- 0.8 ng/ml) compared with prestudy peak levels (1.6 +/- 0.7 ng/ml, p < 0.05) and with the level in the control group (1.5 +/- 0.8 ng/ml, p < 0.05), a toxic concentration was not reached, and toxicity symptoms were not observed clinically. Blood pressure, heart rate, and liver size did not change significantly in any patient during the study.

RCT Entities:   Population Interventions Outcomes