Efficacité d’un dispositif combinant le froid et la vibration pour la gestion de la douleur d’enfants lors de procédures impliquant des aiguilles dans les services d’urgence : un essai clinique randomisé de non-infériorité

Needle-related procedures are considered as the most important source of pain in children in hospital settings. It is now recognized that even minor procedures can result in physiological, psychological and emotional consequences. For these reasons, management of children’s pain and distress through pharmacological and/or non-pharmacological intervention is essential. Healthcare professionals working in the Emergency Department (ED) setting face particular challenges regarding procedural pain management related to their work environment. Time constraints, heavy workload, and busy environment represent barriers to the use of available interventions for pain management during needle-related procedures. Therefore, the use of a rapid, easy-to-use intervention could improve procedural pain management practices in the context of the ED. As such, the Buzzy device, which is a bee-shaped device combining vibration and cold, seems to be a promising alternative. The theoretical bases of this device are the Gate Control Theory and the diffuse noxious inhibitory controls, both generating the modulation of pain.   The primary objective of this study was to determine if a device combining cold and vibration (Buzzy device) was considered as non-inferior (no worse) to a topical anesthetic (liposomal lidocaine 4% cream) for pain management in children undergoing needle-related procedures in the ED.  This randomized, controlled, non-inferiority trial with two parallel groups was conducted in the ED of a university pediatric tertiary hospital center (CHU Sainte-Justine, Montreal, Canada). A total of 352 participants were enrolled and 346 were randomized to either experimental (Buzzy device=172) or control (topical anesthetic=174) groups. For the participants allocated to the experimental, the Buzzy device was applied 5 cm above the insertion site group just before the needle-related procedure and was maintained in place throughout the procedure. For the participants allocated to the control group, a topical anesthetic cream (liposomal lidocaine 4%) was applied at the insertion site 30 minute before the needle-related procedure. Using an intention-to-treat analysis, the mean difference in procedural pain scores between the experimental group (3,92  3,13) and the control group (3,27  3,02) was 0.64 (95%CI -0,10 to 1,26) using the Color Analogue Scale, showing that the Buzzy device was not non-inferior to the topical anesthetic. Regarding the procedural distress, no significant difference was found between groups using the both measuring scales (Procedure Behavior Check List: p=0,104; Children’s Fear Scale: p=0,421). In addition, no significant difference was also found between groups regarding the success of the procedure at first attempt (p=0,489) and the memory for pain 24 hours after the procedure (p=0,346). Parents of both groups were satisfied with the received interventions (p=0,257) and the majority of nurses (65,0%) preferred the Buzzy device over the topical anesthetic. No adverse events occurred in the cold and vibrating group and one adverse event was reported in the topical anesthetic cream group.  The non-inferiority of the cold and vibrating device over a topical anesthetic was not demonstrated for pain management of children during needle-related procedure in the ED.  However, considering that topical anesthetics are underused in the ED setting, the Buzzy device seems to be a promising alternative as it is a rapid, low-cost, easy-to-use and reusable intervention. Consequently, it could be more likely to be translated into clinical practice and adopted by clinicians for routine use.

Keyphrases: Procedural pain, Distress, Needle-related procedures, Pediatric, Nursing interventions, Non-pharmacologic interventions