A comparison of oral midazolam-ketamine, dexmedetomidine-fentanyl, and dexmedetomidine-ketamine combinations as sedative agents in pediatric dentistry: A triple-blinded randomized controlled trial

Introduction: It is common to encounter a patient who is anxious to the magnitude that precludes the possibility of provision of dental treatment. This study aims to evaluate and compare the sedative effect of oral combinations of midazolam-ketamine (MK), dexmedetomidine-fentanyl (DF), and dexmedetomidine-ketamine (DK) in a group of uncooperative children requiring dental treatment. Methodology: This was a prospective, randomized, triple-blind study where 36 children who were 3–9 year old with American Society of Anesthesiologists –I status and presenting early childhood caries were randomly assigned to: Group A – 0.3 mg/kg of M and 5 mg/kg K, Group B – 2 ug/kg of D with 3 ug/kg of F, and Group C – 2ug/kg of D with 5 mg/kg of K in 1 mL honey. Patients' blood pressure, heart rate, and oxygen saturation were recorded from the start of the procedure till discharge. Patients' behavior, sedation status, and wake-up behavior were evaluated with Modified Observer Assessment of Alertness and Sedation Scale and ease of treatment completion by Houpt scale. Results: Hemodynamic changes were statistically insignificant in all three groups. 72.8% of patients in Group A and 58.3% of patients in Group B were successfully sedated during treatment. Behavior improvement was seen in all three groups during treatment with statistically insignificant difference in behavior scores produced by Group C. Ease of treatment completion was moderately better with Group A. Conclusion: Oral DK has a comparable sedative property with oral MK combination. Oral DF promises to be a potential sedative agent for children due to its successful anxiolysis.