Efficacy of Moderate Sedation for Dental Treatment of Young Children

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902395
• Other study ID #: UFG SAP 18189
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2009
• Last updated: January 15, 2015
• Start date: June 2008
• Est. completion date: May 2012

Study information

• Verified date: January 2015
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 36 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Brazil	Dental School	Goiania	Goias

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Goias	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Moreira TA, Costa PS, Costa LR, Jesus-França CM, Antunes DE, Gomes HS, Neto OA. Combined oral midazolam-ketamine better than midazolam alone for sedation of young children: a randomized controlled trial. Int J Paediatr Dent. 2013 May;23(3):207-15. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization		1 month	Yes