Expressed breast milk vs 25% dextrose in procedural pain in neonates, a double blind randomized controlled trial

Abstract

Objective: To compare the effect of expressed breast milk (EBM), 25% dextrose (25 D) and sterile water (SW) on procedural pain in neonates as assessed by the premature infant pain profile (PIPP), changes in heart rate (HR), oxygen saturation (SpO2) and duration of crying.

Design: Prospective, double blind, randomized controlled trial.

Setting: Postnatal ward of a tertiary-care hospital.

Participants: 210 babies who required venipuncture for blood sampling and who were on oral feeds were recruited into the study after parental informed consent.

Methods: The enrolled babies were randomized into intervention groups (EBM, 25% dextrose) and control group (sterile water). Two ml of test solution was given to baby by paladay (a traditional cup with a spout) 2 min before venipuncture. The face and crying of baby were video graphed by an independent, blinded observer. The facial response to pain (brow bulge, eye squeeze, nasolabial furrow) was analysed from the video. Maximum HR and minimum SpO2 were recorded during, and 1, 3 and 5 min after venipuncture by another blinded observer.

Outcome variable: PIPP score, HR, SpO2 and crying time at 0/1/3/5 min after sampling.

Results: 160 babies were considered for final analysis with 50 in 25 D, 62 in EBM and 48 in SW group. The mean PIPP score in the 3 groups were 5.22, 6.84 and 11.22 at 0-30 sec after venipuncture; 4.52, 6.34, and 10.88 at 1-1½ min; 3.96, 6.15 and 9.35 at 3-3½ min; and 3.12, 4.68 and 7.83 at 5-5½ min; respectively (P<0.001). The median crying time was 10, 37.5 and 162 seconds in 25 D, EBM and SW groups, respectively (P<0.001).

Conclusions: EBM significantly reduces procedural pain in neonates though to a lesser extent as compared to 25% dextrose.