INTRODUCTION: During pediatric medication administration, patient safety-related incidents such as sentinel event, adverse event or quasi-failure still occur. OBJECTIVE: To identify risk factors associated with adverse events during the medication of pediatric patients reported by nurses. METHODS: Cross-sectional study, non-probabilistic sampling. From January to October 2021, 411 reports from the Vencer II System were reviewed, of which only 140 reported notifications of incidents during the medication of pediatric patients. Using Root Cause Analysis 38 factors associated with adverse events were investigated. Descriptive and inferential statistics were used. RESULTS: Of the 411 reports reviewed, 140 (34.0%) correspond to incidents
116 (83.0%) to adverse events and 24 (17.0%) to quasi-failure, no sentinel events were reported. In the human factor, six of the seven proximal factors had a frequency ≥ 40%. Work overload was significantly associated with the occurrence of adverse events
OR = 3.24 (95% CI [1.31-7.99]) (p = 0.008). Contrary to what has been reported, LASA (Look-Alike, Sound-Alike) medications and double-check omission were identified as protective against the occurrence of incidents
OR = 0.323 (95% CI [0.13-0.84]) (p = 0.017)
OR = 0.39 (95% CI [0.15-0.99]) (p = 0.047). CONCLUSIONS: Work overload was identified as a risk factor associated with the occurrence of adverse events, so it is necessary to evaluate this factor from objective medication and from the nurses' perception of it. Having a documented incident notification and response system in place will allow healthcare institutions to demonstrate diligence and transparency. Finally, the usefulness of Root Cause Analysis and the Ishikawa Diagram to identify factors that can cause incidents is again supported, so their integration into the VENCER II instrument would be useful.