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Efficacy of Moderate Sedation for Dental Treatment of Young Children

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ClinicalTrials.gov Identifier: NCT00902395
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : January 19, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Dental Caries Child Behavior Conscious Sedation Failure During Procedure Drug: Midazolam Behavioral: Protective stabilization Drug: Midazolam, ketamine Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children
Study Start Date : June 2008
Primary Completion Date : December 2010
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00902395     History of Changes
Other Study ID Numbers: UFG SAP 18189
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015

Keywords provided by Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias:
Preschool children

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