Comparative evaluation of intranasal dexmedetomidine and midazolam as premedication for children undergoing corrective surgery for congenital heart disease: A randomized clinical trial.

BACKGROUND

Premedication is essential in paediatric surgery for smooth induction and anxiety relief. Common agents-ketamine, midazolam, dexmedetomidine, and fentanyl-are administered via intramuscular injection, intravenous infusion, or oral routes, but efficacy varies and no consensus exists on an optimal protocol. Intranasal delivery offers a promising, more comfortable alternative with potential to improve outcomes.

METHODS

This double-blind randomized trial evaluated intranasal dexmedetomidine (1 mcg/kg) (group D) versus midazolam (0.2 mg/kg) as premedication in 90 children (2-12 years) (group M) undergoing corrective surgery for acyanotic congenital heart disease (CHD). Sedation, parental separation anxiety, mask acceptance, and hemodynamic parameters were evaluated.

RESULTS

Acceptable sedation was achieved in 62.2% of children in group D and 53.3% in group M. Group D showed superior anxiolysis during separation from parents (93.3% vs. 73.3%) and better mask acceptance during induction (93.3% vs. 53.3%). A statistically significant but clinically mild decrease in diastolic BP occurred in the dexmedetomidine group without adverse effects.

CONCLUSION

Both drugs were effective as intranasal premedication. However, dexmedetomidine showed better results in sedation, less anxiety upon separation from parents, and greater acceptance of the mask, without significant side effects.