Objectives: To evaluate and compare the efficacy and safety of Intranasal (IN) Dexmedetomidine, Midazolam and Ketamine in producing moderate sedation among uncooperative pediatric dental patients.
Study design: This randomized triple blind comparative study comprises of eighty four ASA grade I children of both sexes aged 4-14 years, who were uncooperative and could not be managed by conventional behavior management techniques. All the children were randomized to receive one of the four drug groups Dexmedetomidine 1 microg/ kg (D1), 1.5 microg/kg (D2), Midazolam 0.2 mg/kg (M1) and Ketamine 5 mg/kg (K1) through IN route. These drug groups were assessed for efficacy and safety by gauging overall success rate and by monitoring vital signs, respectively.
Results: The onset of sedation was significantly rapid with M1 and K1 as compared to D1 and D2 (p = < 0.001). The overall success rate was highest in D2 (85.7%) followed by D1 (81%), K1 (66.7%) and M1 (61.9%), however, the difference among them was not statistically significant (p = > 0.05). Even though all the vital signs were within physiological limits, there was significant reduction in pulse rate (PR) (p = < 0.001) and systolic blood pressure (SBP) (p = < 0.05) among D1 and D2 as compared to M1 and K1. D1, D2 and K1 produced greater intra- and post-operative analgesia as compared to M1. There were no significant adverse effects with any group.
Conclusion: Dexmedetomidine, Midazolam and Ketamine, all the three drugs evaluated in the present study can be used safely and effectively through IN route in uncooperative pediatric dental patients for producing moderate sedation.