Comparison of direct breastfeeding and oral dextrose for pain management during BCG vaccination in neonates: a randomized controlled trial.

Effective neonatal pain management, particularly during procedures like vaccination, is vital to prevent immediate distress and potential long-term negative consequences. While non-pharmacological methods exist, direct comparisons of breastfeeding and oral dextrose for specific vaccinations, such as Bacillus Calmette-Guérin (BCG), are limited. This comparison is especially pertinent for low- and middle-income countries (LMICs) needing accessible, cost-effective strategies. This study compared the effectiveness of direct breastfeeding vs. oral dextrose for pain management during BCG vaccination in neonates. An open-label randomized controlled trial was conducted at a maternity home in North Delhi, India. One hundred thirty stable term neonates were randomized to receive either direct breastfeeding (n = 65) or 25% oral dextrose solution (n = 65) during BCG vaccination. Pain was assessed as the primary outcome using the Neonatal Infant Pain Scale (NIPS). Secondary outcomes included heart rate, oxygen saturation, and crying duration. The mean NIPS scores were significantly lower in the breastfeeding group than in the dextrose group (0.68 ± 1.42 vs. 3.65 ± 2.41, P-value < .001). A substantially higher proportion of breastfed infants experienced no pain (95.4% vs. 44.6%, P-value < .001). Crying duration was also significantly shorter in the breastfeeding group (1.57 ± 4.36 s vs. 11.77 ± 10.87 s, P-value < .001). Direct breastfeeding is significantly more effective than oral dextrose for managing neonatal pain during BCG vaccination. Given its cost-effectiveness, accessibility, and cultural acceptability, breastfeeding should be prioritized as the standard pain management strategy for this procedure in resource-limited settings like LMICs. Healthcare providers should routinely implement breastfeeding for neonatal vaccination pain relief. CRTI registration: CTRI/2021/12/038491.