Breast milk vs 24% sucrose for procedural pain relief in preterm neonates: a non-inferiority randomized controlled trial

J Perinatol. 2022 Jul;42(7):914-919. doi: 10.1038/s41372-022-01352-2. Epub 2022 Feb 23.

Abstract

Objectives: To compare the pain scores between the two groups, breast milk (BM) and 24% sucrose, in preterm neonates undergoing automated heel lance for the blood draw.

Methods: The study is designed as a randomized, single-blinded, non-inferiority trial. Infants born between 30 1/7weeks and 36 6/7 weeks of gestation were randomly assigned to receive either 24% sucrose or expressed BM. The Premature Infant Pain Profile-Revised (PIPP-R) was utilized to provide pain scores.

Results: No differences were noted in the baseline characteristics between the two groups. The quantile regression estimates for PIPP-R scores during the procedure were statistically non-significant at all percentile levels of distribution (50%ile coefficient 0, 95% CI -0.49 to 0.49).

Conclusion: We conclude that BM is not inferior to 24% sucrose in providing analgesia during heel lance in moderate and late preterm infants.

Trial registration: This trial was registered at www.

Clinicaltrials: gov (identifier NCT04898881).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Female
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Milk, Human
  • Pain / prevention & control
  • Pain, Procedural* / prevention & control
  • Sucrose* / therapeutic use

Substances

  • Sucrose

Associated data

  • ClinicalTrials.gov/NCT04898881