Efficacy of the intravenous formulation of fentanyl citrate administered orally as premedication in paediatric patients undergoing open cardiac surgery.

Background: Recently, fentanyl has become prevalent as a sedative premedication.

Methods: A non-inferiority parallel design quadruple-blinded randomised controlled trial of 1- to 7-year-old children scheduled for elective cardiac surgery was conducted. Participants were assigned a 1:1 allocation ratio to a control group (n = 50) given a parenteral formulation of midazolam 0.5 mg/kg and an intervention group (n = 50) given a parenteral formulation of fentanyl 10 μg/kg 30 min before admission to the operating room.

Results: Fentanyl was shown to be inferior when compared to midazolam during inhalational induction but not in the 'after premedication' and 'during separation' periods. A lower percentage of children disliked the medication in the fentanyl group.

Conclusions: A parenteral formulation of fentanyl can be a satisfactory alternative when given orally as a sedative pre-anaesthetic medication in paediatric cardiac surgery before admission to the operating room.