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.
Division of Anaesthesiology, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil.
Thiago Anderson
TA
Moreira
Paulo Sucasas
PS
Costa
Luciane Rezende
LR
Costa
Cristiana Marinho
CM
Jesus-França
Denise Espíndola
DE
Antunes
Hugo Sérgio Oliveira
HS
Gomes
Onofre Alves
OA
Neto
D000284:Administration, Oral; D000766:Anesthesia, Dental / Q000379:methods*; D002652:Child Behavior / Q000187:drug effects; D002675:Child, Preschool; D016292:Procedural Sedation / Q000379:methods*; D003299:Cooperative Behavior; D003448:Crying / Q000502:physiology; D003731:Dental Caries / Q000628:therapy; D003777:Dental Prophylaxis; D003793:Dental Restoration, Permanent; D018691:Excitatory Amino Acid Antagonists / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D007649:Ketamine / Q000008:administration & dosage*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D009068:Movement / Q000502:physiology; D014081:Tooth Extraction
D018691:Excitatory Amino Acid Antagonists; D006993:Hypnotics and Sedatives; D007649:Ketamine; D008874:Midazolam