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Aim: The primary aim of this study is to investigate the efficacy of intranasally administered ketamine plus midazolam for the dental treatment of children.
Methodology: Two- to six-year-old healthy children, came for dental treatment in our institutional setting and due to uncooperative behavior and requiring restorative dental procedures, were recruited for conscious sedation after taking consent form from their parents/guardians. Each child was randomly assigned to one of the two groups: A – Intranasal (IN) administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.2 mg/kg, maximum 5.0 mg); B – Oral administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.5 mg/kg, maximum 20 mg). The primary outcome was the child’s behavior which was assessed through an observational scale using acceptance of sedative administration; memory of intraoperative events; the child’s stress; adverse events; the child’s pain during the procedure. Descriptive statistical analysis was carried out on the data recorded.
Results:‘Adequate’ depth of sedation was achieved in 93% and ‘satisfactory’ completion of treatment was achieved in 89% of cases with intranasal midazolam-ketamine combination. However, sedation effect was deeper in case of oral route sedation procedures (98%), with recovery time of 45 mins-1 hour, which was longer than that of Intra nasal route.
Intranasal route was effective for modifying behavior in mild to moderately anxious children, however, for more invasive or prolonged procedures oral routes is recommended.