Efficacy of Moderate Sedation for Dental Treatment of Young Children

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT00902395
First received: May 13, 2009
Last updated: January 15, 2015
Last verified: January 2015

May 13, 2009
January 15, 2015
June 2008
December 2010   (final data collection date for primary outcome measure)
Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00902395 on ClinicalTrials.gov Archive Site
Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Moderate Sedation for Dental Treatment of Young Children
Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dental Caries
  • Child Behavior
  • Conscious Sedation Failure During Procedure
  • Drug: Midazolam
    Oral midazolam 1.0 mg/kg (maximum 20 mg)
    Other Name: Dormire, Cristalia, Sao Paulo, Brazil
  • Behavioral: Protective stabilization
    Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
    Other Name: No drug administered
  • Drug: Midazolam, ketamine
    Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
    Other Names:
    • Dormire, Cristalia, Sao Paulo, Brazil
    • Ketamin S+, Cristalia, Sao Paulo, Brazil
  • Active Comparator: Midazolam
    Oral midazolam
    Intervention: Drug: Midazolam
  • Experimental: Midazolam/ketamine
    Combined midazolam and ketamine
    Intervention: Drug: Midazolam, ketamine
  • Protective stabilization
    No drug or placebo administered
    Intervention: Behavioral: Protective stabilization
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: 10.1111/j.1365-263X.2012.01246.x. Epub 2012 May 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
12 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00902395
UFG SAP 18189
No
Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
Universidade Federal de Goias
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Luciane R Costa, DDS, MS, PhD Faculty of Dentistry, Federal University of Goias
Principal Investigator: Paulo S Sucasas, MD, MS, PhD Medical School, Federal University of Goias
Study Chair: Thiago A C Moreira, MD Health Sciences Graduate Program, UFG
Study Chair: Denise E Antunes, DDS, PhD Health Sciences Graduate Program, UFG
Study Chair: Cristiana M Jesus-Franca, DDS, PhD Health Sciences Graduate Program, UFG
Study Chair: Hugo S G Oliveira, MD Health Sciences Graduate Program, UFG
Study Chair: Onofre A Neto, MD, PhD Faculty of Medicine, UFG
Universidade Federal de Goias
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP