J Dent Anesth Pain Med.  2025 Apr;25(2):109-122. 10.17245/jdapm.2025.25.2.109.

Comparative evaluation of the effectiveness and acceptance of intranasal dexmedetomidine and intranasal midazolam for sedation in children aged 5–8 years using a mucosal atomizer device: a randomized controlled clinical study

• Lalwani Y
• Dave B
• Shah L

• KMID: 2566702
• DOI: http://doi.org/10.17245/jdapm.2025.25.2.109

Abstract

Background
Patient age, preoperative anxiety, dental requirement, risks associated with pharmaceutical management, safety, parental expectations, and cost influence the choice of pharmacological behavior management. Thus, this randomized controlled clinical study aimed to compare the effectiveness and acceptance of intranasal dexmedetomidine and midazolam for sedation in children aged 5–8 years using a mucosal atomizer device (MAD).
Methods
A total of 48 participants with Frankl’s II behavior were randomly divided into two groups: Group I received intranasal midazolam (0.25 mg/kg), and Group II received intranasal dexmedetomidine (1.5 μg/kg). The primary outcomes assessed were drug acceptance, onset and effectiveness of sedation, and pre-and post-treatment anxiety levels. Secondary measures were also evaluated pre- and post-treatment.
Results
Intranasal dexmedetomidine demonstrated significantly better drug acceptance (P < 0.001). Midazolam had a faster onset but was less effective than dexmedetomidine (P < 0.001). Additionally, dexmedetomidine exhibited better anxiolytic properties than midazolam (P < 0.001).
Conclusion
Dexmedetomidine was better accepted by children aged 5–8 years, was more effective, and had superior anxiolytic properties compared with midazolam.

Keyword

Administration, Intranasal; Anxiety; Dexmedetomidine; Drug Delivery Systems; Midazolam