Intranasal Dexmedetomidine Combined with Oral Chloral Hydrate or Midazolam: RCT Results

In a randomized head-to-head outpatient study of pediatric procedural sedation regimens, Li and colleagues evaluated intranasal dexmedetomidine paired with either oral chloral hydrate (D+C) or oral midazolam (D+M). The authors reported a between-group difference in first-attempt sedation success, with a higher rate in D+M than D+C (95.56% vs 86.67%; P=0.036). Sedation parameters, peri-sedation adverse events, and caregiver-reported post-discharge adverse events within 48 hours were recorded.

The study included 180 children aged 3–6 years with American Society of Anesthesiologists physical status I–II who were scheduled for outpatient diagnostic examinations and enrolled between December 2022 and October 2023. Participants were randomized 1:1 to D+C (n=90) or D+M (n=90), as described by the authors. Outcomes encompassed sedation parameters alongside peri-sedation adverse events and caregiver-reported post-discharge adverse events within 48 hours, forming the comparison set for the reported between-group analyses.

Both arms combined intranasal dexmedetomidine with an oral co-medication—chloral hydrate in one group and midazolam in the other. At that level, the protocol distinction centers on which oral agent was paired with the same intranasal sedative backbone. Beyond first-attempt success, sedation onset time was shorter in the D+C group.

Safety data collection spanned peri-sedation adverse events observed around the procedure and caregiver-reported events after discharge within a 48-hour window. The outcome set incorporated both immediate and short-term post-discharge periods, allowing adverse events to be compared across the two combination regimens within the stated timeframe.

Key Takeaways:

• Authors reported a randomized 1:1 outpatient comparison in 180 children (ages 3–6 years; ASA I–II) undergoing diagnostic examinations, enrolled December 2022–October 2023.
• Reported efficacy contrasts differed by endpoint, with first-attempt success favoring D+M and sedation onset described as shorter with D+C.
• Peri-sedation adverse events and caregiver-reported post-discharge adverse events within 48 hours were recorded for comparison between groups.