Efficacy of Moderate Sedation for Dental Treatment of Young Children

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902395

Enrollment

Registered

2009-05-15

Start date

2008-06-30

Completion date

2012-05-31

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Behavior, Conscious Sedation Failure During Procedure, Dental Caries

Keywords

Preschool children

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.

Interventions

DRUGMidazolam

Oral midazolam 1.0 mg/kg (maximum 20 mg)

BEHAVIORALProtective stabilization

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

DRUGMidazolam, ketamine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 36 Months

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

Design outcomes

Primary

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	2 years

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026