Comparison of analgesic efficacy and safety of caudal dexmedetomidine versus intranasal dexmedetomidine in paediatric infraumbilical surgeries
A randomised controlled trial
European Journal of Anaesthesiology
Submitted January 2026 by Dr Matt Hart
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Summary
This randomised, double-blind non-inferiority trial compared the analgesic efficacy and safety of caudal dexmedetomidine versus intranasal dexmedetomidine as an adjunct to a single-shot caudal block in children aged 1-8 undergoing infraumbilical surgery. The primary outcome was the duration of postoperative analgesia. Secondary outcomes included postoperative pain (FLACC), intra-operative fentanyl requirement, haemodynamics, postoperative sedation, emergence delirium, recovery profile, and 24 hour side effects.
A total of 64 children were randomised (32 per group) with no dropouts. Both groups received 0.2% ropivacaine 1 mL.kg-1 caudally; Group C additionally received caudal dexmedetomidine 1 µg.kg-1 and intranasal saline, whereas Group N received intranasal dexmedetomidine 1 µg.kg-1.
The duration of postoperative analgesia was similar between groups (545 ± 90 min intranasal vs. 527 ± 83 min caudal, P = 0.422). Postoperative FLACC scores were comparable at most time points, though marginally higher at 6 h and ward arrival in the caudal group. Intra-operative fentanyl supplementation and 24 hour paracetamol use were similar.
Haemodynamics were mostly comparable, although the caudal group demonstrated more episodes of intra-operative hypotension (P = 0.016) without requiring vasopressors. Sedation scores were higher in the caudal group for the first 2 hours postoperatively, but recovery times and Modified Aldrete scores were similar. No adverse events (PONV, urinary retention, bradycardia, desaturation, respiratory depression, motor block) were reported in either group.
Commentary
Dexmedetomidine has become a commonly used analgesic adjunct in paediatric anaesthesia, with both caudal and intranasal routes increasingly utilised. This study is valuable in directly comparing the two methods when used alongside a caudal block, which is an evidence gap previously noted in the literature.
Overall, this well-designed noninferiority trial demonstrates that intranasal dexmedetomidine at 1 µg.kg-1 provides postoperative analgesia equivalent to caudal dexmedetomidine when used as an adjunct to a single-shot caudal block in infraumbilical surgery. Intranasal administration avoided the transiently higher sedation and hypotension seen in the caudal dexmedetomidine group and produced a similarly smooth recovery profile, suggesting it may be a useful alternative route, particularly when minimising haemodynamic fluctuation or sedation is desirable.
However, several limitations warrant consideration. The study does not report cumulative intra-operative anaesthetic dosing, which represents a potential confounder for both the sedation profile and recovery characteristics. The proposed mechanism of action of caudal dexmedetomidine is direct action on the spinal nerves, whereas intranasal works by systemic absorption, possibly providing a degree of sedation and reduction in anaesthetic requirements. The observed difference in early postoperative sedation could therefore relate, at least in part, to variations in anaesthetic depth rather than the route of dexmedetomidine administration.
Another limitation is that the homogeneous, predominantly male, urogenital surgical population limits generalisability. Hernia repair, for example, is a common neonatal procedure where caudal anaesthesia is frequently used, and comparative data in this younger cohort would be clinically meaningful.
Furthermore, although no adverse events were observed, the sample size (64 patients) is insufficient to draw any robust conclusions regarding safety, particularly for rare but clinically important complications. Patient or carer centred outcomes such as satisfaction or quality of recovery were also not captured and would have strengthened the clinical relevance of the findings.
Future trials could examine pharmacokinetic comparisons between routes, include larger and more diverse paediatric populations, and address measures of parental satisfaction with both techniques. While this trial supports intranasal dexmedetomidine as a potentially feasible alternative to caudal administration, the small sample size and limited generalisability mean that practitioners who routinely use caudal dexmedetomidine may reasonably await further evidence before altering their current practice.
