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.

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: 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 exclusion 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 s and then moved 5 cm along the limb during the procedure. The refrigerated wings were detached if they bothered the child. The child assessed their pain using the validated Revised Faces Pain Scale. The revised faces pain scale comprised 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 test 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% asked for the refrigerated wings were de to be detatched before the end of the procedure) and 107 in the PATCH group. The baseline characteristics were similar between the 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 faling to demonstrate non-inferiority. CONCLUSIONS: Our study failed to show that the BuzzyⓇ device was not inferior to the lidocaine patch in managing pain in children undergoing needle-related procedures. Tweetable abstract: Pain management in children undergoing a needle-related procedure vaccination: which efficacy for BuzzyⓇ device as an alternative to lidocaine patch? A prospective, randomised study.

Evaluation of the acceptability in France of the vaccine against papillomavirus (HPV) among middle and high school students and their parents.

BACKGROUND: The pathogenic and oncogenic roles of papillomavirus (HPV) infections have been documented and shown to occur in women as well as in men. While other countries have already extended their vaccination guidelines to include boys, in 2019 the French National Authority for Health validated implementation of HPV vaccination in the 2020 vaccination schedule. There is, however, a climate of distrust in regard to vaccination in France, and there have been few studies to date regarding the acceptability of HPV vaccination in boys in France. The aim of this study was, therefore, to evaluate the acceptability of extending the recommendations for HPV vaccination in men, among middle and high school students and their parents. METHODS: Our study (HPVac) was a prospective, multicenter, departmental, and descriptive survey applied to a sample of male middle and high school students attending schools in the Loire-Atlantique department and their parents. It took place from January 2017 to January 2018. RESULTS: We analyzed the information obtained from 127 parent questionnaires and 145 children questionnaires. In terms of acceptability, 36.6% (n = 53) of the children and 37.8% (n = 48) of the parents were in favour of being vaccinated or of having their children vaccinated against HPV (51.7% (n = 75) and 50.4% (n = 64), respectively, were undecided). The perception of a risk stemming from HPV infection was positively associated with acceptability of the HPV vaccine. Being against vaccines in general, being discouraged by their parents, parents thinking that their child is not at risk, and the belief that the vaccine is not mandatory were arguments cited and significantly associated with a willingness to be vaccinated. CONCLUSION: This study revealed a lack of information among boys and their parents about HPV and its vaccination. It also clearly showed that taking time to discuss the consequences of an infection and the merits of being vaccinated can help parents overcome their reluctance. The children then generally go along with their parent's choice.