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Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation

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  • Joji Sado-Filho
  • Karolline Alves Viana
  • Patrícia Corrêa-Faria
  • Luciane Rezende Costa
  • Paulo Sucasas Costa

Abstract

Purpose: The optimal sedative regime that provides the greatest comfort and the lowest risk for procedural sedation in young children remains to be determined. The aim of this randomized, blinded, controlled, parallel-design trial was to evaluate the efficacy of intranasal ketamine and midazolam as the main component of the behavioral guidance approach for preschoolers during dental treatment. Materials and methods: Children under seven years of age, with caries and non-cooperative behavior, were randomized into three groups: (KMIN) intranasal ketamine and midazolam; (KMO) oral ketamine and midazolam; or (MO) oral midazolam. The dental sedation appointments were videotaped, and the videos were analyzed using the Ohio State University Behavioral Rating Scale (OSUBRS) to determine the success of the sedation in each group. Intra- and postoperative adverse events were recorded. Data analysis involved descriptive statistics and non-parametric tests (P

Suggested Citation

  • Joji Sado-Filho & Karolline Alves Viana & Patrícia Corrêa-Faria & Luciane Rezende Costa & Paulo Sucasas Costa, 2019. "Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation," PLOS ONE, Public Library of Science, vol. 14(3), pages 1-14, March.
    • Handle: RePEc:plo:pone00:0213074
    DOI: 10.1371/journal.pone.0213074
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