The 90% effective dose of intranasal dexmedetomidine for procedural sedation in children with congenital heart disease before and after surgery: A biased-coin design up-and-down sequential allocation trial.

Abstract

Intranasal dexmedetomidine can provide adequate sedation during short procedures. However, there are few reports investigating the effective dose of intranasal dexmedetomidine for sedation in children with congenital heart disease (CHD) before and after surgery. Children aged 13-36 months with acyanotic CHD requiring trans-thoracic echocardiography before cardiac surgery were recruited for this study. One month after the cardiac surgery, the same children were studied again. The 90% effective dose was established using a biased-coin design up-and-down sequential method. Onset time, examination time, wake-up time and adverse effects were measured. Safety was evaluated in terms of changes in vital signs. A total of fifty-eight subjects were recruited for this study. The 90% effective dose of intranasal dexmedetomidine for sedation was 2.13 μg/kg (95% CI, 1.73-2.34 μg/kg) in children with CHD before cardiac surgery and 3.51 μg/kg (95% CI, 2.99-3.63 μg/kg) after cardiac surgery (P < .01). There were no differences between the groups in terms of demographic variables, onset time, examination time, wake-up time or adverse effects. The 90% effective dose of intranasal dexmedetomidine for sedation in children with CHD was 2.13 μg/kg before cardiac surgery and 3.51 μg/kg after cardiac surgery.