Journal of the Indian Society of Pedodontics and Preventive Dentistry · 2026
Comparative evaluation of two intranasal sedative agents among children undergoing invasive dental procedures: A randomized crossover clinical trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Havale Raghavendra, Kumar N H Praveen, Balkattu Kashyap, Shrutha Santhebachalli Prakasha, Babu Ramesh, Rajan Shiny Raj, Tuppadmath Kanchan M
Аннотация
BACKGROUND: Dental anxiety is a significant barrier in pediatric dentistry, particularly in children with Frankel's negative behavior ratings. Sedation through the intranasal route offers a rapid and noninvasive alternative with high bioavailability. Among various sedatives, the relative efficacy and acceptance of midazolam and dexmedetomidine in pediatric dental care remain underexplored. Hence, the purpose of the study was to compare the sedative effect, acceptance, and side effects of intranasal dexmedetomidine and intranasal midazolam in anxious children undergoing invasive dental procedures.
METHODOLOGY: A triple-blind, split-mouth, crossover randomized clinical trial was conducted on 40 children aged 4-10 years who required either bilateral pulpectomy or extraction. The study was conducted from September 2024 to October 2025. Participants received intranasal midazolam (0.3 mg/kg) and dexmedetomidine (3 mcg/kg) in separate appointments, with a 2-week washout period between them. Behavior was assessed using the Houpt behavioral rating scale, whereas drug acceptance and side effects were recorded using the al-Rakaf scale. Statistical analysis included the Wilcoxon signed-rank test and Friedman test, with P < 0.05 considered statistically significant.
RESULTS: Midazolam demonstrated significantly higher patient acceptance compared to dexmedetomidine. Behavior scores were significantly greater with midazolam across preoperative, intraoperative, and postoperative phases ( P < 0.002). Both agents showed minimal and nonsignificant differences in side effects, with occasional sneezing and nasal irritation observed. No serious adverse effects or carryover effects were noted.
CONCLUSION: Intranasal midazolam demonstrated relatively effectiveness in comparison to dexmedetomidine regarding patient acceptance and behavioral results, with both drugs having acceptable safety profiles.
METHODOLOGY: A triple-blind, split-mouth, crossover randomized clinical trial was conducted on 40 children aged 4-10 years who required either bilateral pulpectomy or extraction. The study was conducted from September 2024 to October 2025. Participants received intranasal midazolam (0.3 mg/kg) and dexmedetomidine (3 mcg/kg) in separate appointments, with a 2-week washout period between them. Behavior was assessed using the Houpt behavioral rating scale, whereas drug acceptance and side effects were recorded using the al-Rakaf scale. Statistical analysis included the Wilcoxon signed-rank test and Friedman test, with P < 0.05 considered statistically significant.
RESULTS: Midazolam demonstrated significantly higher patient acceptance compared to dexmedetomidine. Behavior scores were significantly greater with midazolam across preoperative, intraoperative, and postoperative phases ( P < 0.002). Both agents showed minimal and nonsignificant differences in side effects, with occasional sneezing and nasal irritation observed. No serious adverse effects or carryover effects were noted.
CONCLUSION: Intranasal midazolam demonstrated relatively effectiveness in comparison to dexmedetomidine regarding patient acceptance and behavioral results, with both drugs having acceptable safety profiles.