Premedication with intravenous midazolam for neonatal endotracheal intubation: A double blind randomized controlled trial

Background: Pain during the neonatal period has been associated with immediate and long-term adverse effects. One of the most frequent painful procedures that neonates face in neonatal intensive care unit is the endotracheal intubation. Midazolam has been a candidate for premedication before neonatal intubation. Our aim was to evaluate the effects of midazolam as the premedication on endotracheal intubation of premature infants during surfactant administration. Materials and Methods: In a double-blind clinical trial, 80 preterm infants were undertaken for tracheal intubation following the use of atropine associated to either midazolam or placebo. Patient's vital signs and general conditions were constantly monitored, and pain was assessed using premature infant pain profile (PIPP) score. Results: The mean ± standard deviation for postnatal age was 95.38 ± 50.04 and 111.63 ± 49.4 min in control and midazolam groups, respectively. The patients in the midazolam group had significantly better outcomes across several intubation outcome measures such as duration of endotracheal intubation (23.5 ± 6.7 vs. 18.8 ± 4.8 s, P = 0.001), oxygen saturation level (88.05% ±13.7 vs. 95.1 ± 1.8%, P = 0.002), intubation failure (34.2% vs. 2.5%, P = 0.0001), awake and resistance during intubation (95% vs. 20%, P = 0.0001), and excellent patient condition during intubation (0% vs. 82.5%, P = 0.0001). In addition, PIPP score was significantly lower in the midazolam group (5.2 ± 2.06 vs. 12.9 ± 2.9, P = 0.0001). Conclusion: Premedication with midazolam in newborns before intubation, can hold promising effects that manifests as better overall outcomes, less complications, better vital signs, more comfortable situation, and lesser pain for these patients.