Pediatric anesthesia & critical care

Comparison of plasma concentration and sedative effect of sublingual and intranasal dexmedetomidine in children: A double‐blind randomised controlled study

Acta Anaesthesiol ScandPublished Randomised controlled trial

Authors' conclusion

Intranasal 2 μg/kg dexmedetomidine resulted in significantly higher peak plasma concentration and time to reach peak plasma concentration than sublingual wafers. Sublingual and intranasal dexmedetomidine resulted in comparable sedation, parental separation and mask acceptance.

Study context

Population
Children 2–12 years, 10–30 kg, scheduled for surgery
Participants
30 children
Comparison
Sublingual vs intranasal dexmedetomidine 2 μg/kg premedication
Primary endpoint
Peak plasma concentration, time to peak plasma concentration and AUC of dexmedetomidine
Methodological detailsdouble-blind
  • Double-blind

Primary result

As reported in the abstract

Peak plasma concentration, time to peak and AUC
GroupValueTime to peak, median (IQR), minutesAUC, median (IQR), ng/mL.h
Group Nmedian 0.764 (IQR 0.650–0.820) ng/mL45 [45-120]1.062 [0.848-1.20]
Group Smedian 0.593 (IQR 0.364–0.754) ng/mL60 [45-60]0.866 [0.520-1.05]

Value

Group Nmedian 0.764 (IQR 0.650–0.820) ng/mL
Group Smedian 0.593 (IQR 0.364–0.754) ng/mL

Time to peak, median (IQR), minutes

Group N45 [45-120]
Group S60 [45-60]

AUC, median (IQR), ng/mL.h

Group N1.062 [0.848-1.20]
Group S0.866 [0.520-1.05]
  • Group N vs Group S: P = 0.014
  • Group N vs Group S: P = 0.814
  • Group N vs Group S: P = 0.031

Further findings

OutcomeP value
Plasma concentration at 30 and 45 minSignificantly higher in Group NP < 0.05

Sedation, parental separation anxiety, mask acceptance, recovery, analgesic requirements

Comparable sedation at 25 min in both groups; parental separation anxiety, mask acceptance, recovery and analgesic requirements comparable

Safety

No child required treatment for decreased heart rate

Original publication

Comparison of plasma concentration and sedative effect of sublingual and intranasal dexmedetomidine in children: A double‐blind randomised controlled study. Acta Anaesthesiol Scand. Published 29 January 2025. doi:10.1111/aas.14583

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