Comparative effect of sedation with oral midazolam plus ketamine versus midazolam only on pre-operative behavioural changes among padiatrics day case dentistry: a prospective randomized control study

Abstract

Introduction: Pediatrics required conscious sedation to allay anxiety and provide optimal conditions to perform procedures. This will enhance minimal separation of the children from their parents, ease of venous access, minimizing unwarranted peri-operative behavioral and psychological stress, and minimizing movement during the procedure

Methodology: This was a prospective randomized double-blind study of ASA I and II patients aged between 3-10years schedule for outpatient dental procedures. Following institutional ethics committee approval, sixty eligible patients whose parents/guardians consented were randomly divided into two groups. Group (M) received oral midazolam 0.5mg/kg alone, and group (MK) received oral midazolam 0.25mg/kg combined with oral ketamine 3mg/kg. Both study drugs were mixed in 0.2ml/kg of Lucozade Boost and administered preoperatively. Data collected included were demographic variables, ease of parental separation, and level of cooperation at intravenous cannulation, onset and duration of sedation and associated of complications.

Results: Our study revealed onset of sedation was significantly faster in group M than group MK; 23.20(±2.04) vs 27.83(±2.71) minutes. P value =0.002. The duration of sedation between the two groups though different was not statistically significant (P- value = 0.608). Sedation scores were higher after 30mins in group M but no excessive sedation was observed. Separation of patients from parents and cooperation at venipuncture was significantly better among patients in group MK compared to group M (P-value =0.036). Intra-operatively more patients had tachycardia and tachypnea in the MK than M group.

Conclusion: Combination of oral midazolam-ketamine is better anxiolytic for parental separation and ease to venipuncture than oral midazolam alone.