Evaluation of Modified Fasting Protocols to Shorten Fasting Time Before Sedation in Children: A Prospective Randomized Noninferiority Trial

Backgrounds: Guidelines for fasting before procedural sedation aim to prevent pulmonary aspiration and are primarily targeted for deep sedation. Our study explored whether a shortened fasting protocol is noninferior to the standard protocol by comparing gastric contents evaluated by ultrasound. Methods: Pediatric patients aged < 3 years, scheduled for elective transthoracic echocardiography under sedation, were randomly allocated to a standard group (4-h fasting) or a modified group (4-h fasting for solid and 1-h fasting for water). Gastric ultrasound was performed to evaluate cross-sectional area (CSA) in supine and right lateral decubitus positions (RLDP), with the upper body elevated at 45°. The primary outcome was the CSA-RLDP (CSA_{RLDP 45}). A noninferiority test was performed applying the delta (Δ) of 2.1. Results: The noninferiority test showed that the modified fasting protocol was noninferior to the standard fasting protocol in terms of CSA_{RLDP 45}, with a mean difference (95% confidence interval) of 0.16 (−0.55 to 0.87) within the noninferiority range of delta. Conclusion: The modified fasting protocol was noninferior to the standard in pediatric patients undergoing sedation for transthoracic echocardiography, as assessed by gastric ultrasound. Trial Registration: ClinicalTrials.gov identifier: NCT05810532.