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

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.

RCT Entities:   Population Interventions Outcomes