Comparison of Fentanyl and Midazolam for the Sedation of Infants Under Mechanical Ventilation; A Randomized Clinical Trial

Neonatal respiratory distress syndrome (NRDS), a life-threatening pulmonary disorder, involves 1% of all deliveries worldwide. Shallow breathing causes restlessness in infants, which itself affects pulmonary function; thus, sedative medications are used to preserve better pulmonary function. There are different opinions about the benefits and superiority of these drugs.
The study purposed to assess and compare the effects of fentanyl and midazolam on the required time of mechanical ventilation in infants with respiratory distress syndrome (RDS).
In this randomized clinical trial, 60 infants with RDS were randomly allocated to 2 groups (30 infants each); the first group underwent sedation with midazolam (0.1 mg/kg), and the second group received 0.5 mcg/kg of fentanyl during ventilation. The duration of hospitalization, required time of ventilation, drug complications, feeding intolerance, as well as pneumothorax incidence and need for re-intubation were recorded and compared between the 2 groups.
Eventually, 60 infants (45 male and 15 female) with a mean gestational age of 37.13±1.22 weeks in the midazolam group and 36.73±1.50 weeks in the fentanyl group underwent analysis (P value=0.449). Infants in the midazolam group had a mean length of stay of 11.96 ± 3.41 days, while mean length of stay was 10.36±3.57 days for infants in the fentanyl group (P value=0.039). Mean duration of mechanical ventilation was 4.6±2.14 days in the midazolam group and 4.06±2.04 days in the fentanyl group (P value=0.252).
The findings suggest that midazolam is a more suitable medication for the sedation of infants under mechanical ventilation in comparison with fentanyl; however, its side effects, such as apnea, pneumonia, and seizure, should be considered.