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Efficacy of Moderate Sedation for Dental Treatment of Young Children

This study has been completed.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias Identifier:
First received: May 13, 2009
Last updated: January 15, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Dental Caries
Child Behavior
Conscious Sedation Failure During Procedure
Drug: Midazolam
Behavioral: Protective stabilization
Drug: Midazolam, ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children

Resource links provided by NLM:

Further study details as provided by Universidade Federal de Goias:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: June 2008
Study Completion Date: May 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Midazolam
Oral midazolam
Drug: Midazolam
Oral midazolam 1.0 mg/kg (maximum 20 mg)
Other Name: Dormire, Cristalia, Sao Paulo, Brazil
Experimental: Midazolam/ketamine
Combined midazolam and ketamine
Drug: Midazolam, ketamine
Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
Other Names:
  • Dormire, Cristalia, Sao Paulo, Brazil
  • Ketamin S+, Cristalia, Sao Paulo, Brazil
Protective stabilization
No drug or placebo administered
Behavioral: Protective stabilization
Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
Other Name: No drug administered

Detailed 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.

Ages Eligible for Study:   12 Months to 36 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00902395

Dental School
Goiania, Goias, Brazil, 74605220
Sponsors and Collaborators
Universidade Federal de Goias
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Luciane R Costa, DDS, MS, PhD Faculty of Dentistry, Federal University of Goias
Principal Investigator: Paulo S Sucasas, MD, MS, PhD Medical School, Federal University of Goias
Study Chair: Thiago A C Moreira, MD Health Sciences Graduate Program, UFG
Study Chair: Denise E Antunes, DDS, PhD Health Sciences Graduate Program, UFG
Study Chair: Cristiana M Jesus-Franca, DDS, PhD Health Sciences Graduate Program, UFG
Study Chair: Hugo S G Oliveira, MD Health Sciences Graduate Program, UFG
Study Chair: Onofre A Neto, MD, PhD Faculty of Medicine, UFG
  More Information

Responsible Party: Luciane Ribeiro de Rezende Sucasas da Costa, Associate Professor, Faculty of Dentistry, Universidade Federal de Goias Identifier: NCT00902395     History of Changes
Other Study ID Numbers: UFG SAP 18189 
Study First Received: May 13, 2009
Last Updated: January 15, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Goias:
Preschool children

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents processed this record on December 09, 2016