Combined oral midazolam-ketamine better than midazolam alone for sedation of young children: a randomized controlled trial.

ABSTRACT

BACKGROUND. There is a lack of clinical trials on paediatric dental sedation. AIM. We investigated whether young children's behaviour improves during dental treatment with oral ketamine/midazolam compared with midazolam alone or no sedation. DESIGN. Healthy children under 36 months of age, presenting early childhood caries were randomly assigned to receive protective stabilization plus combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK), or oral midazolam (1.0 mg/kg) (MS), or no sedative (PS). One observer scored children's behaviour using the Ohio State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no sedative) and treatment session. Data were analysed using nonparametric bivariate tests. RESULTS. Forty-one children were included. In the dental exam session, the sum of OSUBRS scores was similar for the three groups (P = 0.81). In the treatment session, the MK produced more cooperative behaviour than MS and PS (P = 0.01), longer sessions (P = 0.04), and a pattern of homogeneous OSUBRS scores from the reception area (before sedative administration) to the end of the session (P = 0.06). No immediate and post-discharge side effects were observed in groups MK and MS. CONCLUSIONS. The combination of oral midazolam and ketamine is efficacious for guiding the behaviour of children under 3 years old.