Premedication with fentanyl for less invasive surfactant administration (LISA): A Randomized Controlled Trial

Abstract Currently, there is no consensus regarding analgesic premedication before the LISA procedure. In this randomized controlled trial, we compared the level of comfort of preterm infants receiving fentanyl as analgesic versus no fentanyl during LISA procedure. We randomized 34 preterm infants of 28+ 0 − 33+ 6 weeks of gestation with RDS within 6 h of birth to receive either fentanyl (1 µg /kg intravenous) or no premedication during LISA procedure. Primary objective was to assess the proportion of infants to be comfortable during the procedure (R-PIPP score < 10) and secondarily complications occurring during the procedure, hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular hemorrhage (IVH) (≥ grade 3), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality. Proportion of infants with a R-PIPP score < 10 during LISA was significantly higher in the fentanyl group (13/17 (76.5%) vs 6/17 (35.3%); p value 0.036). There were no differences in secondary outcome parameters. Conclusion: Low dose fentanyl during LISA procedure resulted in more comfort in preterm infants and without increased complication of both the LISA procedure and fentanyl administration. Further studies are needed to determine the safest and most effective pharmacologic measures to prevent pain and discomfort during LISA. Trial registration: www.ctri.nic.in id CTRI/2020/08/027144, registration date August 14, 2020