Efficacy of Moderate Sedation for Dental Treatment of Young Children

January 15, 2015 updated by: Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias

Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Goias
      • Goiania, Goias, Brazil, 74605220
        • Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Midazolam
Oral midazolam
Oral midazolam 1.0 mg/kg (maximum 20 mg)
Other Names:
  • Dormire, Cristalia, Sao Paulo, Brazil
Experimental: Midazolam/ketamine
Combined midazolam and 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
Other: Protective stabilization
No drug or placebo administered
Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
Other Names:
  • No drug administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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