Dataset on the pain-relieving effect of local cooling during vaccine injections in preschool children

Background Many evidence-based treatments exist for pain-relief during subcutaneous vaccine injection in children. However, these methods are commonly labor-intensive and not routinely applied in clinical settings. Objectives To evaluate the pain-relieving effect and safety of local cooling during subcutaneous vaccine injection in young children. Methods This was a single-blind, randomized, parallel-group multicenter study conducted at two pediatric clinics in Hyogo Prefecture, which included preschool children aged 3–6 years scheduled for vaccination against Japanese encephalitis or influenza virus. Participants were randomly assigned to either the cooled group (local cooling applied using a cooling pack before vaccination) or the non-cooled group (provided with a room temperature cooling pack). Randomization was performed using a computer-generated block method. The primary endpoint was infant pain, measured using the FLACC scale (Facial expression, Leg movement, Activity, Crying, Consolability), rated by a third party reviewing videos of the vaccination process.