Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trial

Abstract

AbstractThe use of a rapid, easy‐to‐use intervention could improve needle‐related procedural pain management practices in the context of the Emergency Department (ED). As such, the Buzzy device seems to be a promising alternative to topical anesthetics. The aim of this study was to determine if a cold vibrating device was non‐inferior to a topical anesthetic cream for pain management in children undergoing needle‐related procedures in the ED. In this randomized controlled non‐inferiority trial, we enrolled children between 4 and 17 years presenting to the ED and requiring a needle‐related procedure. Participants were randomly assigned to either the cold vibrating device or topical anesthetic (4% liposomal lidocaine; standard of care). The primary outcome was the mean difference (MD) in adjusted procedural pain intensity on the 0–10 Color Analogue Scale (CAS), using a non‐inferiority margin of 0.70. A total of 352 participants were randomized (cold vibration device n = 176, topical anesthetic cream n = 176). Adjusted procedural pain scores' MD between groups was 0.56 (95% CI:−0.08–1.20) on the CAS, showing that the cold vibrating device was not considered non‐inferior to topical anesthetic. The cold vibrating device was not considered non‐inferior to the topical anesthetic cream for pain management in children during a needle‐related procedure in the ED. As topical anesthetic creams require an application time of 30 min, cost approximately CAD $40.00 per tube, are underused in the ED setting, the cold vibrating device remains a promising alternative as it is a rapid, easy‐to‐use, and reusable device.