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Efficacy of Moderate Sedation for Dental Treatment of Young Children

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ClinicalTrials.gov Identifier: NCT00902395
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : January 19, 2015
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

Tracking Information
First Submitted Date  ICMJE May 13, 2009
First Posted Date  ICMJE May 15, 2009
Last Update Posted Date January 19, 2015
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2009)
Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Moderate Sedation for Dental Treatment of Young Children
Official Title  ICMJE Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dental Caries
  • Child Behavior
  • Conscious Sedation Failure During Procedure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2011)
41
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2009)
100
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00902395
Other Study ID Numbers  ICMJE UFG SAP 18189
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
Study Sponsor  ICMJE Universidade Federal de Goias
Collaborators  ICMJE Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE
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
PRS Account Universidade Federal de Goias
Verification Date January 2015

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