Effects of Different Doses of Fentanyl on the Sedation of Infants Under Mechanical Ventilation; A Randomized Clinical Trial

Document Type: Original Article


1 Department of Pediatrics, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, Iran

2 Department of Clinical Pharmacy, Faculty of Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University (IAUPS), Tehran, Iran

3 Student Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, Iran

4 International Otorhinolaryngology Research Association (IORA), Universal Scientific Education and Research Network (USERN), Tehran, Iran


Background: Respiratory distress syndrome (RDS) is a medical emergency in infants resulting from a lack of or deficiency in surfactant, and leads to pulmonary failure. Surfactant and mechanical ventilation are among the primary treatments for helping infants with respiration. Some sedative drugs, such as benzodiazepines and opioids, are used to reduce stress and restlessness in infants under mechanical ventilation.
Objective: This study aimed to evaluate the effect of 2 different dosages of Fentanyl on sedation of infants under mechanical ventilation.
Methods: In this randomized clinical trial, infants with RDS were assessed, and restless infants under mechanical ventilation were included in the trial. Infants were randomly allocated into 2 groups. Infants in group A underwent treatment with 0.5 μg/kg fentanyl, and those in group B received 1 μg/kg of fentanyl. Demographic information as well as data on the duration of mechanical ventilation, length of hospital stay, and need for re-intubation were recorded on a pre-designed checklist.
Results: Ultimately, 60 infants (46 male and 14 female) with a mean gestational age of 36.7±1.48 weeks in group A and 36.2±1.42 weeks in group B underwent analysis (P=0.087). Patients in group A were hospitalized for 10.36±3.59 days, and those in group B were hospitalized for 10±3.95 days (P=0.642). Mean duration of mechanical ventilation was 3.96±2.02 days in group A and 3.51±1.5 days in group B infants (P=0.459).
Conclusion: The findings of the present study suggest that both doses of fentanyl (0.5 μg/kg and 1 μg/kg) reduced all parameters of respiratory distress, such as heart rate and respiratory rate, with no significant difference between the 2 doses.


  1. Lynch RG. Surfactant and RDS in premature infants. Faseb J. 2004;18(13):1624.
  2. Najafian B, Khosravi MH, Setayesh F, Shohrati M. Comparing the effect of Inhaler N-acetyl cysteine and intravenous dexamethasone on respiratory distress syndrome in premature infants: a randomized clinical trial. Thrita. 2017;6(1):e46268. doi: 10.5812/thrita.46268.
  3. Behrman RE, Kliegman RM, Jensen HB. Nelson Textbook of Pediatrics. 2nd ed. Philadelphia: WB Saunders; 2000.
  4. Iqbal Q, Younus MM, Ahmed A, et al. Neonatal mechanical ventilation: Indications and outcome. Indian J Crit Care Med. 2015;19(9):523-527. doi:10.4103/0972-5229.164800.
  5. Najafian B, Karimi-Sari H, Khosravi MH, Nikjoo N, Amin S, Shohrati M. Comparison of efficacy and safety of two available natural surfactants in Iran, Curosurf and Survanta in treatment of neonatal respiratory distress syndrome: A randomized clinical trial. Contemp Clin Trials Commun. 2016;3:55-59. doi:10.1016/j.conctc.2016.04.003.
  6. Hall RW, Boyle E, Young T. Do ventilated neonates require pain management? Semin Perinatol. 2007;31(5):289-297. doi:10.1053/j.semperi.2007.07.002.
  7. Najafian B, Esmaeili B, Khosravi MH. Comparison of Fentanyl and Midazolam for the Sedation of Infants Under Mechanical Ventilation; A Randomized Clinical Trial. Hosp Pract Res. 2017;2(3):63-67. doi:10.15171/hpr.2017.17.
  8. Hall RW, Shbarou RM. Drugs of choice for sedation and analgesia in the neonatal ICU. Clin Perinatol. 2009;36(2):215- 226. doi:10.1016/j.clp.2009.04.001.
  9. Ibrahim M, Jones LJ, Lai NM, Tan K. Dexmedetomidine for analgesia and sedation in newborn infants receiving mechanical ventilation. Cochrane Database Syst Rev. 2016;(9):CD012361. doi:10.1002/14651858.CD012361.
  10. Romantsik O, Calevo MG, Norman E, Bruschettini M. Clonidine for sedation and analgesia for neonates receiving mechanical ventilation. Cochrane Database Syst Rev. 2017;5:Cd012468. doi:10.1002/14651858.CD012468.pub2.
  11. Bhandari V, Bergqvist LL, Kronsberg SS, Barton BA, Anand KJ. Morphine administration and short-term pulmonary outcomes among ventilated preterm infants. Pediatrics. 2005;116(2):352- 359. doi:10.1542/peds.2004-2123.
  12. Tobias JD. Sedation and analgesia in the pediatric intensive care unit. Pediatr Ann. 2005;34(8):636-645. doi:10.3928/0090-4481-20050801-12.
  13. Orsini AJ, Leef KH, Costarino A, Dettorre MD, Stefano JL. Routine use of fentanyl infusions for pain and stress reduction in infants with respiratory distress syndrome. J Pediatr. 1996;129(1):140-145. doi:10.1016/S0022-3476(96)70201-9.
  14. Ancora G, Lago P, Garetti E, et al. Efficacy and safety of continuous infusion of fentanyl for pain control in preterm newborns on mechanical ventilation. J Pediatr. 2013;163(3):645-651.e641. doi:10.1016/j.jpeds.2013.02.039.
  15. Roth B, Schlunder C, Houben F, Gunther M, Theisohn M. Analgesia and sedation in neonatal intensive care using fentanyl by continuous infusion. Dev Pharmacol Ther. 1991;17(3- 4):121-127.
  16. Guinsburg R, Kopelman BI, Anand KJ, de Almeida MF, Peres Cde A, Miyoshi MH. Physiological, hormonal, and behavioral responses to a single fentanyl dose in intubated and ventilated preterm neonates. J Pediatr. 1998;132(6):954-959. doi:10.1016/S0022-3476(98)70390-7.