Intranasal Dexmedetomidine Plus Midazolam Improves Sedation Success Versus Chloral Hydrate in Children

BackgroundCombination 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.MethodsThis 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.ResultsThe 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.ConclusionCompared 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.