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Radiotherapy is an important modality of cancer therapy in childhood. To ensure reliable positioning during the course of therapy, in very young patients sedation is often required. The objective of this study was to evaluate safety and feasibility of repeated sedation during PBT at our institution treating a high number of very young children. We retrospectively analyzed sedation-related data of children receiving PBT at our institution. All patients were enrolled in the prospective registry study KiProReg (DRKS00005363). We investigated the association between sedation-related complications and possible risk factors as head mask, positioning, preexisting dysphagia, concurrent chemotherapy, and age. Complications were categorized as respiratory, cardiovascular, and other. Pearson's chi-squared test or Fisher's exact test was used to quantify associations. Between 2013 and 2018, in total 10,187 sedations in 340 children (152 male, 188 female) were performed. The median age of patients was 3.38 years (range 0.7-16.4 years). For sedation, either propofol only (n=9597) or propofol plus adjuncts (n=590) were applied. Complications occurred in 120 sedations (1.2%) and concerned 66 patients with respiratory (n=105), cardiovascular (n=3), and other (n=12) events. Four patients required hospitalization for respiratory complications (n=2) or complications due to tumor progression (n=2). Head mask (p=0.0001) and preexisting dysphagia were significantly associated with the risk of complication (p=<0.0001). Prone position was not showing any impact on complications. Our study proved safe application of repeated sedation in young patients during radiotherapy with PBT. Evaluating a high number of procedures the complication rate was low. Still, to ensure safety, a multidisciplinary, experienced team is mandatory. [ABSTRACT FROM AUTHOR]