This trial is active, not recruiting.

Conditions dental caries, child behavior, conscious sedation failure during procedure
Treatments midazolam, protective stabilization, midazolam, ketamine
Phase phase 4
Sponsor Universidade Federal de Goias
Collaborator Conselho Nacional de Desenvolvimento Científico e Tecnológico
Start date June 2008
End date December 2010
Trial size 41 participants
Trial identifier NCT00902395, UFG SAP 18189


There is lack of clinical trials on pediatric dental sedation. The purpose of this study is to test (using a randomized controlled trial design) the hypothesis that young children behavior during dental treatment improves with oral midazolam sedation. A further aim of this study was is explore whether behavior also changes over sessions needed to dental treatment completion.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Oral midazolam
midazolam Dormire, Cristalia, Sao Paulo, Brazil
Oral midazolam 1.0 mg/kg (maximum 20 mg)
Combined midazolam and ketamine
midazolam, ketamine Dormire, Cristalia, Sao Paulo, Brazil
Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
No drug or placebo administered
protective stabilization No drug administered
Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.

Primary Outcomes

Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old
time frame: 2 years

Secondary Outcomes

Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization
time frame: 1 month

Eligibility Criteria

Male or female participants from 12 months up to 36 months old.

Inclusion Criteria: - Healthy children (ASA PS 1) - Children under 36 months old - Children presenting early childhood caries - Children with no history of dental treatment Exclusion criteria: - Lost to follow-up

Additional Information

Official title Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children
Principal investigator Luciane R Costa, DDS, MS, PhD
Description There is a lack of clinical trials on pediatric dental sedation in children 3 years old and under. We investigated whether young children's behavior improves during dental treatment with combined oral ketamine and midazolam compared to midazolam alone or no sedation. Healthy children under 36 months of age, presenting early childhood caries and referred to a pediatric dental sedation clinic were randomly assigned to receive combined midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK), oral midazolam (1.0 mg/kg) (MS), or protective stabilization without sedative (PS). One observer scored children's behavior using the Ohio State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no sedative) and treatment session. Data were analyzed using non-parametric bivariate tests.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Universidade Federal de Goias.