Neonatal Pain Response to Various Heel Prick Devices: a Randomized Controlled Trial

BACKGROUND: Heel prick is a commonly performed painful intervention in neonates. Though different devices are available, there is a need to compare the procedural pain response elicited by them. OBJECTIVE: To compare the neonatal pain response to three different heel prick devices; automatic lancet, manual lancet, and 26‐gauge (G) hypodermic needle. DESIGN: Parallel‐group three‐arm randomized controlled trial. PARTICIPANTS: Clinically stable neonates of gestational age >28 weeks and birth weight >800 g undergoing heel prick for estimation of random blood sugar. METHODS: One hundred and eighty neonates were randomized to automatic lancet (n=59), manual lancet (n=59), or needle (n=62) groups between March, 2021 and August, 2022. The primary outcome was the premature infant pain profile‐revised (PIPP‐R) score. Secondary outcomes were post‐intervention cerebral regional oxygen saturation (CrSO2), changes in CrSO2 (DCrSO2), the time for CrSO2 normalization using near‐infrared spectroscopy, duration of audible cry, and the number of squeezes and pricks needed. Intention‐to‐treat analysis was done. RESULTS: Median (IQR) of PIPP‐R scores were comparable in the automatic lancet [6 (4, 7.5)], manual lancet [5.5 (3.5, 8)], and needle [6 (3‐9.6)] groups; P=0.59. No difference was observed in post‐intervention CrSO2, DCrSO2, and the number of pricks. However, the time required for CrSO2 normalization and the number of squeezes were significantly higher with the needle. CONCLUSION: All three devices induced similar pain responses to heel prick in neonates; though, the number of squeezes needed was higher with the needle.