Efficacy of Moderate Sedation for Dental Treatment of Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries Child Behavior Conscious Sedation Failure During Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Midazolam

Oral midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Oral midazolam 1.0 mg/kg (maximum 20 mg)

Midazolam/ketamine

Combined midazolam and ketamine

Group Type EXPERIMENTAL

Midazolam, ketamine

Intervention Type DRUG

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

Protective stabilization

No drug or placebo administered

Group Type OTHER

Protective stabilization

Intervention Type BEHAVIORAL

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

Interventions

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Midazolam

Oral midazolam 1.0 mg/kg (maximum 20 mg)

Intervention Type DRUG

Protective stabilization

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

Intervention Type BEHAVIORAL

Midazolam, ketamine

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

Intervention Type DRUG

Other Intervention Names

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Dormire, Cristalia, Sao Paulo, Brazil No drug administered Dormire, Cristalia, Sao Paulo, Brazil Ketamin S+, Cristalia, Sao Paulo, Brazil

Eligibility Criteria

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Inclusion Criteria

* Healthy children (ASA PS 1)
* Children under 36 months old
* Children presenting early childhood caries
* Children with no history of dental treatment