Breast Milk vs 24 % Sucrose in Procedural Pain Relief in Preterm Infants: Randomized Controlled Trial

Blood draw by automated heel lancet is a common painful procedure in the Neonatal Intensive care units (NICU). The cutaneous sensory receptors on all mucosal and cutaneous surfaces are developed by 20 weeks gestational age (GA) and the neuronal circuits that carry pain stimuli from skin to cerebral cortex are developed by around 26 weeks of GA. Recurrent pain in preterm neonates impacts their postnatal growth, development, is associated with altered pain perception, and increased behavioral responses for future painful procedures.

Oral sucrose is a commonly administered and effective non-pharmacologic intervention used in the NICU for pain relief. There is insufficient evidence on its mechanism of action, minimum effective dose, the effect of repeated doses on long-term neurodevelopmental outcomes, and the consistency in providing pain relief with repeated doses over time. Moreover, the analgesic effect of sucrose is a developmentally transient phenomenon. Another non-pharmacologic intervention studied for pain relief in neonates is breast milk. The analgesic property of breast milk is presumed to be from its sweet taste from lactose, flavor, and odor. Breast milk has high levels of tryptophan, a melatonin precursor which may increase secretion of beta-endorphin, an endogenous opioid.

There is a paucity of data comparing analgesic properties of breast milk and sucrose in preterm neonates, along with insufficient evidence of sucrose as mentioned earlier, The investigator conducted this prospective randomized controlled trial (RCT) comparing sucrose with breast milk for pain relief in preterm neonates.

The primary objective of the study is to compare pain scores between two groups (24% sucrose and breast milk) during blood draw by automated heel lancet, in preterm neonates. The pain scores between the two groups will also be compared at 30 seconds intervals until two minutes post-procedure.

The current study is conducted at Hutzel Women's Hospital and Children's Hospital of Michigan NICU. Institutional Review Board approval was obtained from Wayne State University prior to study initiation. Before the study was initiated, physicians were trained in assessing the PIPP-R pain scale. The pain scores were given by two physicians who were blinded to the treatment arm, at baseline, during, 30-, 60-, 90-, and 120 seconds post-procedure. These scores were given either at the time of the procedure or a video is recorded to be scored later.