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.Objectives: 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 (Delta CrSO2), 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, Delta CrSO2 and the number of pricks. However, the time required for CrSO2 normalization and the number of squeezes were significantly higher with the needle.Conclusions: All three devices induced similar pain responses to heel prick in neonates; though, the number of squeezes needed was higher with the needle.