Efficacy of Moderate Sedation for Dental Treatment of Young Children

Phase 4

Completed

• Conditions: Conscious Sedation Failure During Procedure; Dental Caries; Child Behavior
• Interventions: Drug: Midazolam, ketamine; Behavioral: Protective stabilization; Drug: Midazolam

• Registration Number: NCT00902395
• Lead Sponsor: Universidade Federal de Goias

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-15
• Primary Completion: 2010-12
• Study Completion: 2012-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam/ketamine	Midazolam, ketamine	Combined midazolam and ketamine
Protective stabilization	Protective stabilization	No drug or placebo administered
Midazolam	Midazolam	Oral midazolam

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Dental School; 🇧🇷 Goiania, Goias, Brazil