Dexmedetomidine compared to ketofol for sedation in pediatric patients undergoing dental procedures: a double-blind, randomized clinical trial

Background & objective: Hospital phobia and anxiety are still prevalent issues in the pediatric patients. Various sedative regimes have been in dental practice, but the evidence for safe and effective sedative drugs in this population is scarce. We compared the safety and efficacy of intravenous combination of ketamine plus propofol (ketofol) with dexmedetomidine (Dex) as a sedative premedication in anxious children undergoing dental pulp therapy. Methodology: This double-blind, randomized clinical study recruited 40 anxious children who were to undergo dental pulp therapy. The study participants were allocated into two groups (20 subjects each). Subjects in Group I received ketofol solution (ketamine/propofol mixture, each mL contains 2 mg of ketamine plus 4 mg of propofol). A loading dose of 0.3125 mL/kg was administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h. Subjects in Group II received the Dex solution (4 mu g/mL). A loading dose of 2 mu g/kg was administered IV over 10 min, followed by a maintenance infusion of 0.1-1 mu g/kg/h. Non-invasive blood pressure, SpO2, heart rate (HR), and respiratory rate (RR) were assessed at baseline, at 2 min, and then at 5 min intervals till 60 min. Ramsay sedation score was assessed before, during, and after the procedure and Aldrete's recovery rating score was assessed at the end of the procedure. Results: Compared to the Dex group, the ketofol group showed a statistically significant shorter sedation onset (P = 0.017) but longer discharge time as well as higher rescue dose and a number of interruptions (P < 0.001). There was more stable respiration in Dex group, but with significantly more bradycardia. The mean arterial blood pressure showed some episodes of significant elevations with ketofol compared to Dex, while a biphasic response was observed in the Dex group. Conclusion: The use of Dex induced successful sedation of children who underwent tooth pulp therapy in terms of minimizing the number of interruptions during the procedure, the frequency of rescue drugs administration as well as the total procedure and discharge times. Dexmedetomidine showed no adverse respiratory effects but was associated with bradycardia and biphasic mean blood pressure alterations that require careful titration.