Efficacy of Moderate Sedation for Dental Treatment of Young Children

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.

Conditions

• Dental Caries
• Child Behavior
• Conscious Sedation Failure During Procedure

Interventions

DRUG

Midazolam

Oral midazolam 1.0 mg/kg (maximum 20 mg)

BEHAVIORAL

Protective stabilization

Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.

DRUG

Midazolam, ketamine

Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)

Sponsors & Collaborators

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Universidade Federal de Goias

  lead OTHER

Principal Investigators

• Luciane R Costa, DDS, MS, PhD · Faculty of Dentistry, Federal University of Goias

• Paulo S Sucasas, MD, MS, PhD · Medical School, Federal University of Goias

• Thiago A C Moreira, MD · Health Sciences Graduate Program, UFG

• Denise E Antunes, DDS, PhD · Health Sciences Graduate Program, UFG

• Cristiana M Jesus-Franca, DDS, PhD · Health Sciences Graduate Program, UFG

• Hugo S G Oliveira, MD · Health Sciences Graduate Program, UFG

• Onofre A Neto, MD, PhD · Faculty of Medicine, UFG

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2010-12-31

Completion

2012-05-31

Countries

• Brazil

Study Locations