A double-blind randomized controlled trial to compare the safety and efficacy of dexmedetomidine alone and in combination with ketamine in uncooperative and anxious paediatric dental patients requiring pulpectomy.

Abstract

To compare the sedation regimen Dexmedetomidine alone and its combination with low dose Ketamine through intravenous route in terms of safety, efficacy and recovery profile in uncooperative paediatric dental patients requiring pulpectomy. Thirty anxious and uncooperative 2-6-year-old children requiring pulpectomy in at least one primary molar were enrolled. Propofol was used as an induction agent. Drugs were administered through the intravenous route as per group assignment, i.e., Dexmedetomidine (1µg/kg) with ketamine (0.5mg/kg) administered over 10min followed by a maintenance dose of Dexmedetomidine (0.2-0.8µg/kg/h) in group A and Dexmedetomidine (1µg/kg) administered over 10min followed by a maintenance dose in group B. The sedation was titrated to achieve Houpt's overall behavior score of 4/5. The primary outcome measure was the successful completion of treatment. Secondary outcome measures were vital signs, quality of sedation, time need for the procedure, recovery time, intra-operative and post-operative adverse sequelae. Results showed that both of the regimens were similar in efficacy, safety and recovery profile. Also, the required dose of dexmedetomidine and the need for rescue boluses was similar in both of the study groups. Dexmedetomidine either alone or in combination with ketamine proved to be a safe and efficacious agent for paediatric dental sedation. No beneficial evidence of adding ketamine was observed.