Analgesic effect of expressed breast milk in procedural pain in term neonates: a randomized, placebo-controlled, double-blind trial

Acta Paediatr. 2004 Apr;93(4):518-22. doi: 10.1080/08035250410022792.


Aim: To assess the effectiveness of expressed breast milk (EBM) in reducing pain due to venepuncture, in term neonates, as measured by behavioural and physiological observations.

Methods: This randomized, placebo-controlled, double-blind trial involved 81 full-term neonates, up to 4 wk of postnatal age, who needed venepuncture for blood investigations. Two minutes before the venepuncture, in the intervention arm, 40 babies received 5 ml of EBM, while 41 babies in control group received 5 ml of distilled water (DW) as placebo. Two observers who were blinded to the intervention recorded the physiological (heart rate and oxygen saturation) and behavioural parameters [duration of crying and modified Neonatal Facial Coding Scores (NFCS)] after the venepuncture.

Results: There was no difference in the baseline characteristics of the neonates in the two groups. The duration of crying was significantly shorter in babies fed EBM [median 38.5 s, interquartile range (IQR) 9.5-57.5 s] than in those fed DW (median 90 s, IQR 28-210 s). The mean duration of crying in EBM group was shorter by 70.7 (95% confidence interval 36.6-104.9) s. The modified NFCS at 0, 1 and 3 min was significantly lower (p < 0.01) in the EBM than in the DW group. The change in heart rate and oxygen saturation was significantly lower in the EBM group and returned to baseline values sooner than in the DW group.

Conclusion: Feeding 5 ml of EBM before venepuncture is effective in reducing symptoms due to pain in term neonates.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Analgesia / methods*
  • Blood Specimen Collection / adverse effects
  • Blood Specimen Collection / methods*
  • Crying*
  • Diagnostic Techniques and Procedures / adverse effects
  • Double-Blind Method
  • Female
  • Health Status Indicators
  • Humans
  • Infant, Newborn
  • Male
  • Milk, Human*
  • Pain / prevention & control*
  • Pain Measurement / methods
  • Placebo Effect