Efficacy of Enhanced Dose of Expressed Breast Milk in Neonatal Procedural Pain Relief: A Randomised Placebo-controlled Study

Introduction: Procedural pain remedies in neonates is an area of active research due to better understanding of short and long-term outcomes of neonatal painful exposures. Non pharmacological interventions are especially attractive as it avoids unnecessary drug exposure. While dextrose is known to be effective, results with small volumes (2 mL) of Expressed Breast Milk (EBM) are equivocal. There is recent theoretical evidence to show that larger doses of EBM may be more efficacious. Aim: To compare the efficacy of a larger volume of EBM 5 mL and 2 mL of 25% Dextrose (25D) in relief of procedural pain from venipuncture in term and preterm neonates. Materials and Methods: A single center randomised placebo- controlled study was conducted at Bokaro General Hospital, Bokaro Steel City, Jharkhand, India, between March 2014 and February 2016. Neonates ≥34 week gestation, requiring venipuncture in a neonatal care unit were randomly allocated into 3 equal groups using a random number table- Sterile Water (SW), 2mL 25D, 5 mL EBM was given two minutes prior to venipuncture. Video of facial response, cry times, Maximal Heart Rate (MHR), and minimum Oxygen Saturation (SpO2) were recorded till five minutes after venipuncture. The Premature Infant Pain Profile (PIPP) score was used to assess the effect of the interventions on procedural pain. Subgroup analysis was done in term and preterm neonates. Continuous variables were presented as mean±SD or median. Categorical variables were expressed as frequencies and percentages. The comparison of normally distributed continuous variables between the groups was performed using Analysis of Variance (ANOVA). Results: The PIPP score in the 25D group (2.94±1.41) was significantly lower than the EBM (7.42±1.69) and SW (10.56±1.69) groups (p-value<0.001). MHR was significantly lower in the 25D group, but no difference was found between the EBM and SW groups (p-value=0.23). SpO2 was significantly higher in the 25D group but for the initial 2.5 minutes only. Cry times were significantly lower in the intervention groups. There was no difference in outcomes in term vs. preterm infants. Conclusion: The use of 2 mL 25D was more effective in reducing procedural pain from venipuncture compared to 5 mL EBM. The return of physiological markers (MHR and SpO2) to baseline were faster and more complete in the 25D group.