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

Background: Neonatal respiratory distress syndrome (NRDS), a life-threatening pulmonary disorder, involves ۱% 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. Objective: 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). Methods: In this randomized clinical trial, ۶۰ infants with RDS were randomly allocated to ۲ groups (۳۰ infants each); the first group underwent sedation with midazolam (۰.۱ mg/kg), and the second group received ۰.۵ 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 ۲ groups. Results: Eventually, ۶۰ infants (۴۵ male and ۱۵ female) with a mean gestational age of ۳۷.۱۳±۱.۲۲ weeks in the midazolam group and ۳۶.۷۳±۱.۵۰ weeks in the fentanyl group underwent analysis (P value=۰.۴۴۹). Infants in the midazolam group had a mean length of stay of ۱۱.۹۶ ± ۳.۴۱ days, while mean length of stay was ۱۰.۳۶±۳.۵۷ days for infants in the fentanyl group (P value=۰.۰۳۹). Mean duration of mechanical ventilation was ۴.۶±۲.۱۴ days in the midazolam group and ۴.۰۶±۲.۰۴ days in the fentanyl group (P value=۰.۲۵۲). Conclusion: 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.

Keywords:

Midazolam , Fentanyl , Respiratory Distress Syndrome , Mechanical Ventilation