NCT00902395

Efficacy of Moderate Sedation for Dental Treatment of Young Children

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Universidade Federal de Goias · Academic / Other
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries
• Child Behavior
• Conscious Sedation Failure During Procedure

Interventions

Type	Name	Description
DRUG	Midazolam	Oral midazolam 1.0 mg/kg (maximum 20 mg)
BEHAVIORAL	Protective stabilization	Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
DRUG	Midazolam, ketamine	Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-12-01
• Completion: 2012-05-01
• First posted: 2009-05-15
• Last updated: 2015-01-19

Locations

1 site across 1 country: Brazil