The effectiveness of the Buzzy® device to reduce or prevent pain in children undergoing needle-related procedures: the results from a prospective, open-label, randomised, non-inferiority study: Prevention of pain in child's vaccination: a randomised control trial

Abstract Background Pain from needle-related procedures in children can alter pain perception, increase pain sensitivity, and generate inappropriate pain responses. Currently pain management includes the use of lidocaine-containing patches, which is complicated to manage in a busy medical setting such as a vaccination centre. We assessed the Buzzy® device, which combines vibration and cold, to manage pain in children undergoing a needle-related procedure compared to the standard lidocaine patch. Design Prospective, open-label, non-inferiority trial. Setting Conducted in the vaccination centres of three university hospitals in France Participants French speaking children aged 4-15 requiring a needle-related procedure (vaccination or venepuncture) were eligible. Principal non-inclusion criteria were allergy or sensitivity to the lidocaine patch. Methods Children were randomly allocated (1:1) to use either the Buzzy® device or the lidocaine patch during the needle-related procedure. The lidocaine patch was applied to the puncture site for the hour prior to the intervention. The Buzzy® device was applied to the puncture site for 30 seconds and then moved 5 cm along the limb during the procedure. The refrigerated wings could be detached if they bothered the child. The child assessed their pain using the validated Revised Faces Pain Scale. The revised faces pain scale comprises six facial expressions from 0, normal “no pain” to 10, a screaming face “severe pain” (2 points/face). The primary endpoint was the average pain score recorded by the child. The study aimed to show the non-inferiority of Buzzy®. Results Overall 219 participants were randomised. The primary outcome was assessed in 215 children: 108 in the BUZZY group (43% did not want to use the refrigerated wings until the end of the procedure) and 107 in the PATCH group. The baseline characteristics were similar study groups with an average age of 9 (range: 4.08-15.81). The average needle-related pain was 2.04 in the BUZZY group and 1.42 in the PATCH group. The average difference between the children's assessments in the groups was 0.62. Thus, not demonstrating non-inferiority. However, concerning parents’ assessments, the mean difference between groups was 0.30 points, demonstrating non-inferiority of the BUZZY group compared to the PATCH group. Conclusions Our study failed to show that the Buzzy® device was equivalent to the lidocaine patch in managing pain in children undergoing needle-related procedures. The Buzzy® device does seem to be more effective when the refrigerated wings are accepted by children, but the impact of temperature on the children's comfort remains unclear. Tweetable abstract: Pain management in children undergoing a vaccination: which efficacy for Buzzy® device as an alternative to lidocaine patch? A prospective, randomised study.