KETOMED Study Protocol: Ketonemia and emergence delirium in a multicenter study

Emergence Delirium (ED) following general anaesthesia affects up to a third of paediatric patients. Its multifactorial aetiology suggests that the metabolic state derived from preoperative fasting plays a significant role. Ketonemia, a physiological state associated with fasting, has been minimally investigated as an independent risk factor for ED. The KETOMED study aims to determine whether preoperative ketonemia is independently associated with the development of emergence delirium in the paediatric population.

Multicentre observational study in paediatric patients under general anaesthesia. Participants will be grouped based on the presence or absence of ED, defined using the Paediatric Anaesthesia Emergence Delirium (PAED) scale. Inclusion and exclusion criteria have been based on age, surgical type, and anaesthesia protocol. Main outcome will be ED and its association with ketone levels. Secondary outcomes include other clinical and sociodemographic risk factors and parental satisfaction.

Despite the number of studies showing the beneficial role of ketone bodies in cerebral development, little is known of their potential role in the induction of ED. KETOMED addresses this issue in a robust prospective study using validated tools, including the Spanish translation of the PAED scale.

KETOMED is expected to establish evidence supporting the implementation of low-cost preoperative ketonemia screening. The results have the potential to guide clinical practice regarding fasting management and clear fluid administration, ultimately aiming to reduce the incidence of ED and improve the quality and safety of paediatric anaesthetic recovery.