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Intranasal fentanyl for pain management during screening for retinopathy of prematurity in preterm infants: a randomized controlled trial

Journal of Perinatology volume 40, pages 881–887 (2020)Cite this article

Subjects

Abstract

Objective

To study the efficacy of intranasal fentanyl as an adjunct for pain management during screening for retinopathy of prematurity (ROP) in preterm infants.

Study design

In this single center, double blinded, randomized controlled trial, preterm neonates between 30 and 34 weeks postmenstrual age received either intranasal fentanyl (2 mcg/kg) or intranasal normal saline through a mucosal atomization device 5 min prior to the first ROP-screening examination. Both the groups received standard pain relief strategies (oral sucrose, 0.5% proparacaine eye drops and physical containment). The primary outcome was premature infant pain profile-revised (PIPP-R) score during the screening.

Results

A total of 111 infants were enrolled. PIPP-R score during the retinal examination was significantly lower in the fentanyl group (8.3 versus 11.5, mean difference: 3.2 (2.46–4.06), P < 0.001). There was no significant difference in the incidence of adverse effects.

Conclusion

Intranasal fentanyl significantly reduced the pain associated with retinal examination without increasing the risk of respiratory depression. Large RCTs are required to verify the efficacy and safety of intranasal fentanyl for acute procedural pain in neonates.

Clinical Trial Registration

CTRI/2017/12/011016.

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Acknowledgements

None of the authors received any grant for producing the manuscript.

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Authors and Affiliations

  1. Surya Hospital, Mumbai, Maharashtra, India

    Mythily Sindhur, Haribalakrishna Balasubramanian, Nandkishor S. Kabra, Prachi Agashe & Ashish Doshi

  2. The Children’s Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA

    Lakshmi Srinivasan

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  1. Mythily Sindhur
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Contributions

HB and MS conceptualized and designed the study. MS recorded the study data and drafted the first manuscript. LS and NK conducted the literature search and critically reviewed the manuscript. PA and AD supervised the conduct of the study and critically reviewed the manuscript. All authors approved the submission of this version of manuscript and take full responsibility for the manuscript.

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Correspondence to Haribalakrishna Balasubramanian.

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Sindhur, M., Balasubramanian, H., Srinivasan, L. et al. Intranasal fentanyl for pain management during screening for retinopathy of prematurity in preterm infants: a randomized controlled trial. J Perinatol 40, 881–887 (2020). https://doi.org/10.1038/s41372-020-0608-2

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