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Efficacy of Moderate Sedation for Dental Treatment of Young Children

Primary Purpose

Dental Caries, Child Behavior, Conscious Sedation Failure During Procedure

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Midazolam

Protective stabilization

Midazolam, ketamine

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Preschool children

Eligibility Criteria

12 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Midazolam

Midazolam/ketamine

Protective stabilization

Arm Description

Oral midazolam

Combined midazolam and ketamine

No drug or placebo administered

Outcomes

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

Secondary Outcome Measures

Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization

Full Information

NCT ID

NCT00902395

First Posted

May 13, 2009

Last Updated

January 15, 2015

Sponsor

Universidade Federal de Goias

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT00902395

Brief Title

Efficacy of Moderate Sedation for Dental Treatment of Young Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Goias

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries, Child Behavior, Conscious Sedation Failure During Procedure

Keywords

Preschool children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Midazolam

Arm Type

Active Comparator

Arm Description

Oral midazolam

Arm Title

Midazolam/ketamine

Arm Type

Experimental

Arm Description

Combined midazolam and ketamine

Arm Title

Protective stabilization

Arm Type

Other

Arm Description

No drug or placebo administered

Intervention Type

Drug

Intervention Name(s)

Midazolam

Other Intervention Name(s)

Dormire, Cristalia, Sao Paulo, Brazil

Intervention Description

Oral midazolam 1.0 mg/kg (maximum 20 mg)

Intervention Type

Behavioral

Intervention Name(s)

Protective stabilization

Other Intervention Name(s)

No drug administered

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Midazolam, ketamine

Other Intervention Name(s)

Dormire, Cristalia, Sao Paulo, Brazil, Ketamin S+, Cristalia, Sao Paulo, Brazil

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

36 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: