Katia Lescop1, Isabelle Joret2, Paola Delbos3, Valérie Briend-Godet4, Sophie Blanchi5, Christian Brechet6, Annastasia Galivel-Voisine7, Sandrine Coudol8, Christelle Volteau9, Valéry-Pierre Riche10, Emmanuelle Cartron11. 1. CHU de Nantes, Centre fédératif prévention dépistage, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: katia.lescop@chu-nantes.fr. 2. CHU de Nantes, Centre fédératif prévention dépistage, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: Isabelle.joret@chu-nantes.fr. 3. CHU de Nantes, Centre fédératif prévention dépistage, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: paola.delbos@chu-nantes.fr. 4. CHU de Nantes, Centre fédératif prévention dépistage, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: valerie.briendgodet@chu-nantes.fr. 5. CH le Mans, Centre de Prévention Vaccination et Dépistage, Service des maladies infectieuses et tropicales, 194 Avenue Rubillard, 72037 Le Mans, France. Electronic address: sblanchi@ch-lemans.fr. 6. CHD Vendée, Centre fédératif de prévention et de dépistage, Les Oudairies, 85 925 La Roche sur Yon cedex 9, France. Electronic address: christian.brechet@chd-vendee.fr. 7. CHU de Nantes, Direction de la recherche et de l'innovation, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: annastasia.galivelvoisine@chu-nantes.fr. 8. CHU de Nantes, Clinique des données, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: sandrine.cioudol@chu-nantes.fr. 9. CHU de Nantes, Direction de la recherche et de l'innovation, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: christellevolteau@gmail.com. 10. Service Evaluation Economique et Développement des Produits de Santé, Department of Clinical Research, CHU de Nantes, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: valerypierre.riche@chu-nantes.fr. 11. CHU de Nantes, Direction de la recherche et de l'innovation, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France; INSERM, SPHERE U1246 "Methods in Patients-centered Outcomes and Health Research", Nantes University, Tours University, Nantes, France. Electronic address: emmanuelle.cartron@chu-nantes.fr.
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: The vaccination centres of three university hospitals in France. PARTICIPANTS: French speaking children aged 4-15 requiring aneedle-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.
RCT Entities:
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.