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

The 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  = 176, topical anesthetic cream  = 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.