Safety and Efficacy of IV Dexmedetomidine as an Adjunct to Propofol to Sedate Anxious and Uncooperative Pediatric Dental Patients: A Randomized Controlled Trial

Abstract

Objective : To evaluate the safety and efficacy of dexmedetomidine (dex) as an adjunct to propofol sedation in pediatric dental patients. Study design: This RCT enrolled 30 anxious ASA-I 2-5 year olds. Allocated into 2 groups either receiving IV propofol (1 mg/kg)(Gp-P) or [IV dex (1ug/kg) with propofol(1 mg/kg)] (Gp-D) after oral midazolam premedication (0.5 mg/kg). Sedation maintained with propofol infusion at 50–75ug/kg/min. Additional bolus/es of propofol (1mg/kg) was/were administered in case of inadequate sedation. Primary outcome was to compare requirement of propofol in two groups. Secondary outcomes were to compare vital signs, depth of sedation, induction, treatment and recovery time, intra & post-operative complications and analgesic requirement post-operatively. Results : Total propofol (in mgs) used and number of additional boluses were significantly higher in group P (p<0.05). Although within normal limits, heart rate was significantly lower in group D. Respiratory rate, oxygen saturation, NIBP were comparable. Depth of sedation achieved was comparable at all steps (p>0.05). Induction time (mins) was significantly lower in Group P (p<0.05), however treatment and recovery time were similar (p>0.05). Desaturation was observed in 3/15(group P) & 0/15(group D). Analgesic requirement post-operatively was significantly higher in group P (p<0.05). Conclusion: Dexmedetomidine is a safe and effective adjunct to propofol.