Comparative Sedation Efficacy of Dexmedetomidine and Ketofol in Pediatric Dental Procedures: A Double-Blind, Randomized Clinical Trial
Keywords:
Pediatric, Endodontic treatment, Human, Premedication, Hypnotics, Ketofol, Sedatives, Sedation, DexmedetomidineAbstract
Background & objective: Pediatric patients continue to struggle with hospital fear and anxiety. Even with the use of several sedative protocols in clinics and hospitals, there is insufficient data to prove their safety and efficacy in those patients. This research sought to assess the risks and benefits of intravenous ketamine mixed with propofol (ketofol) versus dexmedetomidine (Dex) as sedative premedications for scared children undergoing endodontic treatment.
Methodology: In our randomized double-blind clinical trial, we chose 40 anxious children who were scheduled for endodontic treatment. They were divided into two groups (20 kids each). Group I was given a ketofol solution (ketamine and propofol combination, with 2 and 4 milligram of ketamine and propofol per milliliter, respectively). The first loading dosage was 0.3125 mL/kg, given intravenously (IV) over 10 min, followed by an infusion of 0.05–0.125 mL/kg/h. Group II received a loading dose of 2 μg/kg of Dex solution (4 μg/mL) given IV over 10 min, followed by an infusion of 0.1–1 μg/kg/h. Oxygen saturation (SpO2), heart rate (HR), non-invasive blood pressure (BP), and respiratory rate (RR) were measured at baseline, at two min intervals, and every five min for up to 1 h. Ramsay sedation score was measured pre- and postoperatively. Aldrete’s recovery rating score was measured postoperatively as well.
Results: Group I showed a remarkably shorter sedation onset (P = 0.017) than group II. However, in group I, the discharge time was longer and rescue dose and interruption frequency were higher (P < 0.001) than in group II. Participants in group II, who were given Dex, had more stable respiration but experienced a significantly higher incidence of bradycardia than those in group I. The mean arterial blood pressure (ABP) in group I showed more significant rise than in group II. However, the biphasic response was noted in group II.
Conclusion: The administration of Dex provided effective sedation for pediatric patients receiving endodontic treatment, as demonstrated by few interruptions throughout the process, a low requirement for rescue drugs, and short total procedure and discharge durations. Although Dex did not cause any adverse respiratory impacts, it was connected to bradycardia and biphasic changes in mean BP, necessitating cautious dosing.
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