Efficacy and safety of sevoflurane in reducing intravenous sedation and the risk of delirium in pediatric patients prolongedly ventilated and intubated in the PICU

Abstract

BACKGROUND: Delirium has a global incidence rate of 25% in PICU, representing a significant morbidity challenge in daily clinical practice. Sevoflurane has proven to be effective in clinical trials involving adult patients in hospitals in France, as well as in a prospective observational study involving pediatric patients in hospitals in Spain. Based on these findings, this study aims to evaluate the efficacy and safety of sevoflurane in a controlled clinical trial to reduce the incidence of delirium in these patients. OBJECTIVE: The primary objective of the study is to analyze the effectiveness and safety of sevoflurane in reducing the need for intravenous sedation, and consequently the risk of delirium, in PICU patients aged 2 to 16 years, who are intubated and mechanically ventilated for more than four days and require drug rotation. STUDY DESIGN AND PARTICIPANTS: This is a randomized, multicenter, single-blind clinical trial with a blinded statistician. It includes a total of 768 patients, with 384 participants allocated to each group. The sample is stratified into three age groups (2-4 years, 5-9 years, and 10-16 years), with 256 patients per age group. METHODS: Two drug rotation protocols will be administered across the two study groups: a control group that receives intravenous sedation only; and an intervention group that receives inhaled sedation with sevoflurane in addition to standard protocols. As a multicenter study, training sessions will be conducted at each participating hospital by the director of the study, to ensure standardized implementation of the protocols, data collection and maintenance of uniform environmental conditions. All data will be analyzed by a professional statistician, and the results, whether expected or not, will be disseminated through the appropriate channels