Evaluation of Oral Midazolam and Oral Midazolam-Ketamine for Paediatric Dentistry

Objectives: To compare the effectiveness of addition of oral ketamine to oral midazolam with oral midazolam alone for conscious sedation in outpatient paediatric dentistry.
Methods: A prospective randomized double blind study of ASA I and II patients aged between 3-10years who presented at UDUTH for outpatient dental procedures. Following institutional 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: ease of parental separation, degree of cooperation at intravenous cannulation, onset and duration of sedation and vital signs. P-value was set at 0.05.
Results: Demographic parameters were similar in both groups. Onset of sedation was significantly faster in group M than group MK; 23.20(±2.04) vs 27.83(±2.71) minutes. P =0.002. The duration of sedation between the two groups though different was not statistically significant. P=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. Intraoperatively, more patients had tachycardia and tachypnea in the MK than M group. Mean arterial pressures and peripheral oxygen saturation were essentially similar in both groups in the first 90 minutes following drug administration. No bradycardia was observed in any group.
Postoperative complications were nausea and vomiting which were significantly higher in the MK group.
Conclusions: Though onset of sedation was faster with midazolam sedation alone, the combination of oral midazolam-ketamine provided better sedative conditions for parental separation of patients and venipuncture than oral midazolam alone. Combination of midazolam with ketamine for sedation caused more tachycardia, nausea and vomiting than when only midazolam is used.