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

Int J Paediatr Dent. 2013 May;23(3):207-15. doi: 10.1111/j.1365-263X.2012.01246.x. Epub 2012 May 28.


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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Anesthesia, Dental / methods*
  • Child Behavior / drug effects
  • Child, Preschool
  • Conscious Sedation / methods*
  • Cooperative Behavior
  • Crying / physiology
  • Dental Caries / therapy
  • Dental Prophylaxis
  • Dental Restoration, Permanent
  • Excitatory Amino Acid Antagonists / administration & dosage*
  • Female
  • Follow-Up Studies
  • Humans
  • Hypnotics and Sedatives / administration & dosage*
  • Ketamine / administration & dosage*
  • Male
  • Midazolam / administration & dosage*
  • Movement / physiology
  • Tooth Extraction


  • Excitatory Amino Acid Antagonists
  • Hypnotics and Sedatives
  • Ketamine
  • Midazolam