Using a Decision-making System to Support the Management of Fever and Acute Pain in Children

FEVER is a single-center, prospective, open-label, pre-market, pivotal, single-arm study aimed at demonstrating how the use of an algorithm integrated with a Class I Medical Device (Puntofarma®), which is made available through a downloadable mobile phone app, can, given specific input, improve the appropriateness and adherence to therapy for the management of fever and pain in children between 3 months and 1 day and 5 years of age. 100 patients are expected to be enrolled, equally distributed between febrile patients (50%) and patients with acute pain (50%). Patients admitted to the Regional Pediatric Emergency Department of the Meyer IRCCS Hospital in the presence of a feverish episode and/or acute pain will be enrolled upon discharge. The study will last a total of 8 months (Jan - Aug 2026), with enrollment expected by Jan 2026. Each patient will be involved in the study for a maximum of 7 days from enrollment, during which they will use the mobile app. Participation in the study will conclude by the seventh day of use of the app, with the completion of a satisfaction questionnaire.

Inclusion Criteria: * Pediatric patients, male or female, between 3 months and 1 day and 5 years of age, who have a fever and are prescribed paracetamol, or who have already received a prescription for an antipyretic from an outside physician before accessing the emergency room. * Pediatric patients, male or female, between 3 months and 1 day and 5 years of age, who have acute pain and are prescribed paracetamol, or who have already received a prescription for an analgesic from an outside physician before accessing the emergency room. * Pediatric patients whose caregivers have knowledge of the Italian language. * Pediatric patients whose caregivers have access to the internet and have a smartphone that is either the latest generation or no older than five years. Exclusion Criteria: * Pediatric patients, male or female, aged less than 3 months and over 5 years. * Pediatric patients who have experienced adverse reactions or contraindications to paracetamol administration. * Pediatric patients whose caregivers have little or no knowledge of the Italian language. * Pediatric patients whose caregivers do not have internet access or do not have a latest-generation smartphone or, in any case, one no older than five years.