The impact of automatic devices for capillary blood collection on efficiency and pain response in newborns: A randomized controlled trial.

Background: The heel stick is the method of choice in most neonatal units for capillary blood sampling, and it represents the most common event among all painful procedures performed on newborns. The type and design of heel stick device and the clinical procedure to collect a blood sample may have an impact on newborn pain response as well.

Objective: To compare the pain response and efficiency of different automated devices for capillary blood collection in newborns.

Design: Randomized clinical trial.

Setting: Postnatal ward of a tertiary-care university hospital in Italy.

Participants: Newborn infants at gestational age ≥34 weeks undergoing the metabolic screening test after the 49th hour of life.

Methods: A total of 762 neonates were recruited and randomized into 6 groups (127 babies in each group) assigned to 6 different capillary blood collection devices (Ames Minilet™ Lancet; Cardinal Health Gentleheel; Natus Medical NeatNick™; BD Quikheel™ Lancet; Vitrex Steriheel Baby Lancet; Accriva Diagnostics Tenderfoot).

Main Outcome Measures: The following data were collected and assessed for each of the 6 groups evaluated: a) number of heel sticks, b) pain score according to the Neonatal Infant Pain Scale (NIPS) and c) need to squeeze the heel.

Results: The Ames Minilet™ Lancet device was found to perform by far the worst compared to the five device underexamination: it required the highest number of sticks (mean=3.91; 95% CI: 3.46-4.36), evoked the most intense pain (mean=3.98; 95% CI: 3.77-4.20), and most frequently necessitated squeezing the heel (92.9%; 95% CI: 86.9-96.3). The five devices under examination appeared to be similar in terms of the number of sticks required, but differed slightly in NIPS score and in need to squeeze the heel.

Conclusion: The Accriva Diagnostics Tenderfoot device demonstrated the greatest efficiency for blood sampling and evoked the least pain. With this device, the metabolic screening test could be performed with a single skin incision in the large majority of infants (98.4%), heel squeezing was limited to only 6.3% of infants, and the NIPS score turns out to be lower than other devices in our study (1.22; 95% CI 1.05-1.39).