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. 2025 Apr;25(2):109-122.
doi: 10.17245/jdapm.2025.25.2.109. Epub 2025 Mar 27.

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

Yash Lalwani  1 , Bhavna Dave  1 , Lipsa Shah  1
Affiliations

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

Yash Lalwani et al. J Dent Anesth Pain Med. 2025 Apr.

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.

Keywords: Administration, Intranasal; Anxiety; Dexmedetomidine; Drug Delivery Systems; Midazolam.

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Conflict of interest statement

DECLARATION OF INTERESTS: The authors declare no conflict of interest related to this study. This study was conducted without external funding.

Figures

Fig. 1
Fig. 1. Consolidated standards of reporting trials (CONSORT) flow diagram. n, number; UMSS, University of Michigan sedation scale.
Fig. 2
Fig. 2. Administration of dexmedetomidine/midazolam using a mucosal atomizer device (MAD).
Fig. 3
Fig. 3. Bar graphs showing pre- and post-treatment comparison of hemodynamic vital parameters. Group M, midazolam group; Group D, dexmedetomidine group.
Fig. 4
Fig. 4. Inter group comparison of drug acceptance and effectiveness.
Fig. 5
Fig. 5. Inter group comparison of pre and post treatment anxiety levels. Group M, midazolam group; Group D, dexmedetomidine group.
Fig. 6
Fig. 6. Box-plot comparing inter group anxiety (pre-operative, post-operative and difference). Group 1, midazolam group; Group 2, dexmedetomidine group.
See this image and copyright information in PMC

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