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). 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, 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.