Comparative efficacy and post-discharge adverse events of intranasal dexmedetomidine combined with different oral medications for procedural sedation in children: a randomized controlled trial.

Background: Combination sedation regimens are widely used in pediatric procedural sedation. However, the efficacy and incidence of post-discharge adverse events between intranasal dexmedetomidine combined with oral chloral hydrate and intranasal dexmedetomidine combined with oral midazolam remain unclear. Methods: This was a single-center, prospective, randomized controlled trial. A total of 180 children aged 1-6 years with American Society of Anesthesiologists physical status I-II who were scheduled for outpatient procedural sedation between December 2022 and October 2023 were enrolled and randomly assigned to receive intranasal dexmedetomidine combined with oral chloral hydrate (D+C group, n = 90) or intranasal dexmedetomidine combined with oral midazolam (D+M group, n = 90). The primary outcome was first-attempt sedation success. Secondary outcomes included the incidence of caregiver-reported post-discharge adverse events within 48 h, the incidence of peri-sedation adverse events, sedation onset time, procedure duration, recovery time, children's medication acceptance, and parental satisfaction. Results: The first-attempt sedation success rate was significantly higher in the D+M group than in the D+C group (95.56% vs. 86.67%, P = 0.036). Sedation onset time was shorter in the D+C group (P < 0.001), whereas recovery time and peri-sedation adverse events were comparable between the two groups. Children's medication acceptance and parental satisfaction were lower in the D+C group (P < 0.001). During the 0-48 h period after discharge, the D+C group had higher incidences of somnolence, ataxia, and any adverse event (all P < 0.05). Multivariable analysis confirmed that the D+M regimen was independently associated with lower risks of several post-discharge adverse events but a higher risk of behavioral changes. Phi coefficient analysis suggested clustering of adverse events, with neurologic symptoms tending to co-occur. Conclusion: Compared with the D+C regimen, the D+M regimen provides a higher first-attempt sedation success rate and fewer post-discharge adverse events, although attention to post-discharge behavioral changes remains necessary.