Study Design and Participants
critically ill, Raynaud disease, rash, neurodevelopmental or behavioral disorders, infection, peripheral neuropathy, nerve damage
HYPERSENSITIVITY DISEASES, CRITICALLY ILL, RAYNAUD DISEASE, PRADER-WILLI SYNDROME, FRANKLIN, MAY, INFECTION, COLD, PERIPHERAL NEUROPATHY, BLEEDING DISORDERS
This study was designed as a prospective randomized (1:1) open-label study. Between May 2021 and January 2022, we enrolled patients aged between 29 days and 18 years who had to undergo a planned routine outpatient blood sampling at the Pediatrics Unit of Pisa University Hospital, Pisa, Italy, dividing them into 3 age groups (29 days to <3 years, ≥3 to ≤8 years, >8 years). While the patients were waiting for venipuncture, the study's aims and methods as well as the Buzzy device functioning were explained to the parents and to older children. If they agreed to participate, written consent was obtained from at least 1 parent and from children older than 12 years, together with general information. Children undergoing intravenous cannulation or invasive procedures different from venipuncture were excluded, together with those refusing to wear the device or with significant needle phobia. We also excluded those who knew or had already used the Buzzy device, as well as those with bleeding disorders; presence of infection, rash, abrasion, or generally damaged skin in the area where the device would be placed; neurodevelopmental or behavioral disorders; critically ill or unstable patients; use of topical, enteral, or parenteral analgesics within 24 hours of presentation; nerve damage or peripheral neuropathy in the area of venipuncture, and cold hypersensitivity diseases such as Raynaud disease and Prader-Willi syndrome. If the child was eligible and the informed consents were signed, for each age group, patients were randomly assigned to either the BUZZY group (venipuncture with Buzzy) or the NO BUZZY group (venipuncture without Buzzy). Both enrollment and randomization were stratified by age; randomization was based on every other patient, and every child was randomized (1:1) in each age group. Venipuncture was performed by means of the Vacutainer (BD Vacutainer, Franklin Lakes, NJ) system, using a 21G butterfly needle. All venipuncture procedures were performed by the same nurse with more than 5 years' experience in pediatric assistance and venipuncture, who had received information and practical training in the use of the Buzzy device. Each child could participate in the study only once.