Efficacy of Moderate Sedation for Dental Treatment of Young Children

Ketamine

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.

Intervention / Treatment

  • Midazolam (DRUG)
    Oral midazolam 1.0 mg/kg (maximum 20 mg)
  • Protective stabilization (BEHAVIORAL)
    Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
  • Midazolam, ketamine (DRUG)
    Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)

Condition or Disease

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

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 12 Months to 36 Months
    Enrollment: 41 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jun 01, 2008
    Primary Completion: Dec 01, 2010 ACTUAL
    Completion Date: May 01, 2012 ACTUAL
    Study First Posted: May 15, 2009 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 15, 2015

    Sponsors / Collaborators

    Lead Sponsor: Universidade Federal de Goias
    Responsible Party: N/A

    Location

    Goias, Brazil
    Goiania, Goias, Brazil

    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.

    Participant Groups

    • Oral midazolam

    • Combined midazolam and ketamine

    • No drug or placebo administered

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 3
    Age Groups: Child
    Healthy Volunteers: Yes

    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
    • 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
    Secondary Outcomes
    • Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization 1 month

    More Details

    NCT Number: NCT00902395
    Other IDs: UFG SAP 18189
    Study URL: https://clinicaltrials.gov/study/NCT00902395
    Last updated: Sep 29, 2023