Oxygen Supplementation in Pediatric Sedation: Prospective, Multicenter, Randomized Controlled Trial

Summary

This multicenter randomized trial assigned 253 children undergoing moderate-to-deep sedation to no supplemental oxygen, low-flow nasal-cannula oxygen (2–6 L/min), or high-flow nasal cannula (2 L/kg/min at FiO2 0.50); 250 completed the protocol. Hypoxemia (SpO2 95% or lower for more than 5 seconds) occurred in 27.6% without oxygen, 7.2% with low-flow oxygen, and 1.2% with high-flow oxygen. Both oxygen strategies reduced hypoxemia versus no oxygen; high flow was not statistically superior to low flow (OR 0.143, 95% CI 0.017–1.245). A subsequent open-access critique notes that the trial was not designed to establish equivalence/noninferiority between low-flow and high-flow oxygen, and the physiological outcome was largely transient desaturation.

Why it matters

For pediatric moderate/deep sedation, the regimen studied supports routine low-flow oxygen as a practical method to reduce monitored desaturation. It does not establish that HFNC is necessary or that supplemental oxygen substitutes for capnography, airway readiness, or active ventilation assessment.

Main findings

• Hypoxemia occurred in 27.6% with no oxygen, 7.2% with low-flow oxygen, and 1.2% with HFNC (overall P<0.001).
• Versus no oxygen, odds of hypoxemia were lower with low-flow oxygen (OR 0.184, 95% CI 0.067–0.503) and HFNC (OR 0.026, 95% CI 0.003–0.207).
• HFNC was not statistically superior to low-flow oxygen (OR 0.143, 95% CI 0.017–1.245; P=0.078); rescue interventions were 52.9%, 10.8%, and 3.6%, respectively.
• Open-access post-publication critique: the study cannot demonstrate equivalence/noninferiority of low-flow and high-flow oxygen and has limited ED generalizability.

Limitations

The setting, procedures, staffing, and largely propofol-based sedation regimen may not match ED procedural sedation. The primary threshold captured brief SpO2 changes; the trial was underpowered for clinically meaningful differences between low-flow and HFNC and did not establish equivalence.