Clinical trial NCT00902395: Efficacy of Moderate Sedation for Dental Treatment of Young Children
Official title: Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Child Behavior
Conscious Sedation Failure During Procedure
Keywords: Preschool children
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2009-05-15
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization
timeFrame: 1 month
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Dental School
state: Goias
Study officials:
affiliation: Faculty of Dentistry, Federal University of Goias
name: Luciane R Costa, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical School, Federal University of Goias
name: Paulo S Sucasas, MD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Sciences Graduate Program, UFG
name: Thiago A C Moreira, MD
role: STUDY_CHAIR
affiliation: Health Sciences Graduate Program, UFG
name: Denise E Antunes, DDS, PhD
role: STUDY_CHAIR
affiliation: Health Sciences Graduate Program, UFG
name: Cristiana M Jesus-Franca, DDS, PhD
role: STUDY_CHAIR
affiliation: Health Sciences Graduate Program, UFG
name: Hugo S G Oliveira, MD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, UFG
name: Onofre A Neto, MD, PhD
role: STUDY_CHAIR
References:
citation: Moreira TA, Costa PS, Costa LR, Jesus-Franca 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: 10.1111/j.1365-263X.2012.01246.x. Epub 2012 May 28.