Background: The volume of pediatric Procedural Sedation and Analgesia (PSA) outside the operating room has been increasing. This high clinical demand leads non-anesthesiologists, especially pediatric intensivists, pediatricians, and emergency physicians, to take a role in performing procedural sedation. Our department has established the PSA service by pediatric intensivists since 2015. Objectives: We aimed to assess the efficacy and safety of PSA outside the operating room conducted by pediatric intensivists and identify risk factors for severe adverse events. Methods: This was a retrospective descriptive study conducted from January 2015 to July 2019. Children aged less than 20 years who underwent procedural sedation were included. We collected demographic data, sedative and analgesic medications, American Society of Anesthesiologists (ASA) Physical Status Classification, indications for sedation, the success of procedural sedation, and any adverse events. Results: Altogether, 395 patients with 561 procedural sedation cases were included. The median age was 55 months (range: 15 to 119 months), and 58.5% (231/395) were male. The rate of successful procedures under PSA was 99.3%. Serious Adverse Events (SAE) occurred in 2.7%. Patients who received more than three sedative medications had higher SAE than patients who received fewer medications (adjusted for age, location of sedation, type of procedure, and ASA classification) (odds ratio: 8.043; 95% CI: 2.472 - 26.173, P = 0.001). Conclusions: Our data suggest that children who undergo procedural sedation outside the operating room conducted by pediatric intensivists are safe and effectively treated. Receiving more than three sedative medications is the independent risk factor associated with serious adverse events.

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