Efficacy of Oral Ketamine and Midazolam Combination versus Oral Midazolam Alone as Premedicants in Paediatric Surgical Patients: An Interventional Study

Introduction: In paediatric patients midazolam and ketamine are commonly used as premedicants, intended to reduce emotional trauma and ensure smooth induction. Hence, we undertook a study to evaluate if addition of oral ketamine 3 mg/kg to oral midazolam 0.5 mg/kg resulted in better premedication than oral midazolam 0.5 mg/kg alone. Aim: To evaluate whether the addition of oral ketamine 3 mg/ kg to oral midazolam 0.5 mg/kg results in more effective premedication compared to oral midazolam 0.5 mg/kg alone in paediatric surgical patients. Materials and Methods: The present interventional study was conducted on 100 children who were assigned equally to the two groups (n=50 each) aged eight months to six years belonging to ASA grade I and II undergoing elective surgeries. Group KM received oral ketamine 3 mg/kg with midazolam 0.5 mg/kg and group M received oral midazolam 0.5 mg/kg 30 minutes prior to proposed surgery. Sedation score, anxiolysis score, parental separation and mask tolerance was assessed in all patients 30 minutes after the drug administration. The data was analysed by using statistical Statistical Package for Social Sciences (SPSS) software. The p-values <0.05 were considered statistically significant, and 95% confidence intervals are reported where applicable. Results: A total of 100 children were randomly divided equally into two groups. The mean age was 3.42±1.48 years in group KM and 3.81±1.69 years in group M, while the mean weight was 12.24±3.59 kg and 13.64±3.77 kg, respectively. Gender and ASA status were comparable between the groups. Satisfactory sedation was achieved in 72% of children in group KM compared to 54% in group M. Anxiolysis was significantly better in group KM (80% score IV) than in group M (24% score IV). Parental separation was smoother in group KM (96% calm separation) compared to 78% in group M. Mask tolerance was also superior in the KM group. All differences were statistically significant (p<0.05). Conclusion: Oral ketamine 3 mg/kg with midazolam 0.5 mg/ kg produces significantly better sedation, anxiolysis, parental separation and mask acceptance without significant side effects when compared to oral midazolam 0.5 mg/kg alone. The quality of sedation, anxiolysis and separation parameters are significantly better in midazolam and ketamine combination group.