Grasse

Peripheral intravenous catheterization is a common procedure in pediatric emergency and hospital settings that often causes significant anxiety and pain for children and their parents. This study evaluates the use of PARO, a therapeutic robot shaped like a baby seal, to help manage pain during this procedure in children aged 12 months to 7 years. The trial is a multicenter, randomized, open-label study involving 120 infants and children, aiming to determine if PARO combined with standard care improves pain relief compared to standard care alone. The study compares two groups: one receiving a standard multimodal pain management strategy including pharmacological and non-pharmacological interventions, and the other group receiving the same strategy supplemented with the PARO robot. Topical anesthesia (EMLA cream) may be applied 30 to 60 minutes before the procedure, and if needed, analgesia with an equimolar mixture of oxygen and nitrous oxide (MEOPA) is given during catheterization. The robot is introduced about 15 minutes before the procedure to help familiarize the child with it. The procedure includes skin disinfection, vein identification, needle insertion, and ends with needle removal and dressing application. Participants will be closely monitored throughout the catheterization, and pain will be assessed using the FLACC scale during the needle procedure. Secondary measures include distress levels, heart rate variability, number of attempts, parental anxiety, and satisfaction of parents and healthcare staff. The study involves detailed observations and questionnaires to evaluate the effectiveness of PARO in improving the child's comfort and reducing anxiety and pain during the procedure.