Intranasal Dexmedetomidine with Propofol Provides Superior Sedation for Pediatric Contrast-Enhanced CT: A Randomized Controlled Trial.

BACKGROUND

Effective and safe sedation with rapid recovery remains a critical unmet need for pediatric patients undergoing contrast-enhanced computed tomography (contrast-enhanced CT). We compared the efficacy of intranasal dexmedetomidine (DEX) combined with intravenous propofol (D-P) versus DEX with buccal midazolam (D-M) for sedation during pediatric contrast-enhanced CT.

METHODS

In this single-center, prospective, randomized controlled trial, 110 children (6 months-6 years, ASA I/II) were allocated to D-M (2 μg/kg intranasal DEX + 0.2 mg/kg buccal midazolam) or D-P (2 μg/kg intranasal DEX + 1 mg/kg intravenous propofol). Primary outcome was one-time success rate (completed contrast-enhanced CT without additional sedation). Secondary outcomes included onset time, recovery metrics (Ramsay Sedation Scale [RSS] at 30 minutes, time to oral intake), and adverse events. Analyses followed full-analysis-set (FAS) and per-protocol-set (PPS) principles (ChiCTR2300067469).

RESULTS

The D-P group demonstrated superior one-time success rates in both FAS (96.4% vs 74.5%; OR 9.05, 95% CI 1.95-42.05, P =0.001) and PPS analyses (96.4% vs 77.1%; OR 7.88, 95% CI 1.65-37.6, P =0.003). Sedation onset was faster with D-P (median 17 vs 20 minutes, P < 0.001), with 98.2% achieving sleep within 20 minutes versus 54.5% for D-M. Recovery was accelerated in D-P: 61.8% attained RSS ≤3 by 30 minutes (vs 30.9%, P < 0.001), and 77.3% resumed oral intake within 1 hour (vs 25.4%, P < 0.001). Bradycardia occurred more frequently with D-P (29.1% vs 5.4%, P =0.001), but no interventions were required.

CONCLUSION

Intranasal dexmedetomidine combined with propofol significantly improves sedation success, accelerates recovery, and reduces procedural delays in pediatric contrast-enhanced CT compared to midazolam, offering a clinically advantageous regimen for short-duration imaging.