Short-term respiratory outcome of mechanically ventilated preterm infants treated by dexmedetomidine: randomized controlled trial

Background The evidence of routine use of sedatives in mechanically ventilated preterm infants is not established because of adverse effects of commonly used drugs. Dexmedetomidine (DEX) is an emerging alternative. Objective To assess safety and efficacy of DEX use as a sedative in mechanically ventilated preterm neonates. Patients and methods A double-blind, randomized controlled trial was conducted on 40 preterm infants less than or equal to 32 weeks of gestation who required mechanical ventilation (MV) during the first 5 days of life. They were randomly assigned to receive DEX (0.1 μg/kg/h) during the first 5 days or placebo. Time to first extubation was our primary outcome, and secondary outcomes were plasma Krebs von den Lundgen-6 at seventh day, bronchopulmonary dysplasia, total duration of MV, total duration of oxygen supplementation, need for postnatal steroid, pain score, necrotizing enterocolitis, intraventricular hemorrhage, patent ductus arteriosus, need for positive inotropes, retinopathy of prematurity requiring intervention, days to reach 100 ml/kg enteral feeds, adverse effects of DEX, and mortality. Results A total of 40 neonates (20 in each group) were enrolled. DEX use was associated with earlier extubation of mechanically ventilated preterm infants (P=0.001) compared with placebo. Durations of respiratory support and MV were significantly shorter in DEX group compared with placebo. DEX therapy was associated with lower level of serum Krebs von den Lundgen-6 and Echelle de Douleur et d’Inconfort du Nouveau-ne pain score compared with placebo. Patients in DEX group have less need to fentanyl dosing and low incidence of sepsis and intraventricular hemorrhage. There was no significant difference between groups regarding other secondary outcomes. There is no significant difference between groups regarding adverse effects. Conclusion We concluded that DEX has beneficial effect on short-term respiratory outcome in mechanically ventilated preterm infants without significant effect on neonatal mortality.