Triple Combination vs. Breastfeeding (Tetanalgesia) for Neonatal Pain Relief

Overview

This randomized clinical trial evaluated whether a non-pharmacological Triple Combination of expressed breast milk, sucking, and facilitated tucking reduced pain during heel prick in healthy term newborns compared with Breastfeeding (Tetanalgesia). The study included healthy term newborns with a gestational age of 37 weeks or more whose parents provided informed consent in the maternity unit of Hospital Comarcal de Vinaròs, Spain. Pain and response to the procedure were assessed by comparing the two groups, and two investigators who were not involved in data collection independently reviewed the video recordings to assign pain scores.

The study was designed as a randomized, single-blind clinical trial with two study groups. Healthy term newborns were recruited consecutively from January 2021 to March 2023 in the maternity unit of Hospital Comarcal de Vinaròs (Castellón, Spain). After informed consent was obtained from parents or legal representatives, participants were allocated by simple randomization using sealed envelopes to one of two study groups: Triple Combination or Breastfeeding (Tetanalgesia). In the Triple Combination group, neonates were placed in a lateral flexed position with the arms and legs close to the trunk. Sucking with a pacifier or finger was started 2 minutes before the heel prick and continued until 2 minutes after the procedure. During the procedure, 1 to 2 mL of freshly expressed breast milk was administered by syringe, while facilitated tucking was maintained throughout the procedure and for 2 minutes afterward. In the Breastfeeding (Tetanalgesia) group, neonates were breastfed during the heel prick while being held in their mothers' arms. The procedure started after approximately 2 minutes of effective sucking and ended 2 minutes after the heel prick. Pain outcomes were assessed using the Premature Infant Pain Profile (PIPP) and the Neonatal Infant Pain Scale (NIPS). Additional outcomes included heart rate and oxygen saturation at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick, as well as crying duration in seconds from the start of the heel prick until crying ceased, assessed up to 5 minutes after heel prick. Two independent investigators who were not involved in data collection reviewed the video recordings to assign pain scores.