dc.description.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
