Efficacy of Moderate Sedation for Dental Treatment of Young Children

Universidade Federal de Goias

Status and phase: Completed; Phase 4

Conditions: Dental Caries; Child Behavior; Conscious Sedation Failure During Procedure

Treatments: Behavioral: Protective stabilization; Drug: Midazolam; Drug: Midazolam, ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00902395

UFG SAP 18189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 12 to 36 months old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Midazolam

Active Comparator group

Description:

Oral midazolam

Treatment:

Drug: Midazolam

Midazolam/ketamine

Experimental group

Description:

Combined midazolam and ketamine

Treatment:

Drug: Midazolam, ketamine

Protective stabilization

Other group

Description:

No drug or placebo administered

Treatment:

Behavioral: Protective stabilization