Evaluation of efficacy of intranasal midazolam, ketamine and their mixture as premedication and its relation with bispectral index in children with tetralogy of fallot undergoing intracardiac repair.

We compared the efficacy of intranasal midazolam, ketamine and their mixture as premedication in children with tetralogy of Fallot (TOF) using bispectral index (BIS), sedation score and separation score at the time of separation from parent. Sedation score at the time of intravenous cannulation was also measured. Children with TOF physiology were randomly divided into three equal groups of 20 each. Group-A received intranasal ketamine (10 mg/Kg), Group-B received intranasal midazolam (0.2 mg/Kg), while Group-C received a mixture of ketamine (7.5 mg/Kg) and midazolam (0.1 mg/Kg) intranasally. After 30 minutes of premedication, sedation and separation score were noted. BIS values were recorded at 5 minutes intervals. A 4-point scale for sedation, separation and acceptance of intravenous cannulation was used. Sedation was good in midazolam group (group B-3.25 +/- 0.44), but the separation and acceptance of intravenous catheter was poor (2.9 +/- 0.31 and 2.85 +/- 0.37 respectively). Sedation scores in group A and C were excellent (3.75 +/- 0.44 and 3.80 +/- 0.41 respectively). Separation from parent was excellent in group A (ketamine) and group C (mixture) (group A- 3.90 +/- 0.28 and group C- 3.83 +/- 0.35 respectively). Children of both these groups allowed easy placement of intravenous cannula. At BIS values < 90, the sedation achieved was good. BIS values decreased with increase in sedation scores in groups who received intranasal midazolam and mixture containing ketamine and midazolam (group B and C respectively), while it remained high in children who received ketamine. We conclude that intranasal ketamine is better than intranasal midazolam. The combination of two is better than midazolam alone but provides no benefit as compared with ketamine alone.

RCT Entities:   Population Interventions Outcomes