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Comparison of nitrous oxide/midazolam and nitrous oxide/promethazine for pediatric dental sedation: A randomized, cross-over, clinical trial.

ABSTRACT: Background:This study compared the safety and efficacy of nitrous oxide (N2O)/midazolam and N2O/promethazine for dental treatment of uncooperative children. Materials and Methods:In this randomized, cross-over, clinical trial investigation Eighteen healthy uncooperative children with a pair of similar teeth requiring the same treatment were included. Combination of N2O/midazolam was given in one visit, where N2O/promethazine was administrated in the other appointment for each patient in a cross-over manner. Oxygen saturation and heart rate as well as behavior parameters according to Houpt behavior scales were recorded. Postoperatively, patients' anxiety and parents' satisfaction were assessed by visual analog score and a questionnaire, respectively. Data were analyzed using Wilcoxon' s signed rank test and Paired t-tests with a P value set at 0.05. Results:Physiologic parameters were within normal limit in both groups. Children in midazolam group were significantly deeper sedated compared to other groups. In the first phase, children sedated with midazolam behaved superiorly in comparison to promethazine, while there was no difference at the final phase of the treatment between the two groups. Conclusion:Both of the drug combinations resulted in acceptable, efficient, and safe sedation outcomes.

SUBMITTER: Mozafar S

PROVIDER: S-EPMC6243808 | biostudies-literature | 2018 Nov-Dec

REPOSITORIES: biostudies-literature

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Comparison of nitrous oxide/midazolam and nitrous oxide/promethazine for pediatric dental sedation: A randomized, cross-over, clinical trial.

Mozafar Sedigheh S Bargrizan Majid M Golpayegani Mojtaba Vahid MV Shayeghi Shahnaz S Ahmadi Rahil R

Dental research journal 20181101 6

<h4>Background</h4>This study compared the safety and efficacy of nitrous oxide (N<sub>2</sub>O)/midazolam and N<sub>2</sub>O/promethazine for dental treatment of uncooperative children.<h4>Materials and methods</h4>In this randomized, cross-over, clinical trial investigation Eighteen healthy uncooperative children with a pair of similar teeth requiring the same treatment were included. Combination of N<sub>2</sub>O/midazolam was given in one visit, where N<sub>2</sub>O/promethazine was administ ...[more]

PMID: 30534169

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Project description:BackgroundUncooperative children may need to receive dental treatment under sedation, which is indicated when nonpharmacological behavior guidance is unsuccessful. There are randomized controlled trials (RCTs) comparing different sedative protocols for dental procedures; however, the evidence for superiority of one form over another is weak. The primary aim of this study is to investigate the efficacy of intranasally administered ketamine plus midazolam for the dental treatment of children.MethodsWe have designed a three-armed, parallel RCT to assess intranasal sedation using ketamine/midazolam in terms of the following measures: efficacy, safety, and cost-effectiveness. Two- to 6-year-old healthy children, referred for dental treatment in a dental sedation center in Brazil due to uncooperative behavior and requiring restorative dental procedures, will be recruited. Each child will be randomly assigned to one of the three groups: A - Intranasal administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.2 mg/kg, maximum 5.0 mg); B - Oral administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.5 mg/kg, maximum 20 mg); and C - Oral administration of midazolam (1.0 mg/kg, maximum 20 mg). The primary outcome is the child's behavior assessed through an observational scale using digital videos of the restorative dental treatment under sedation. The secondary outcomes are as follows: acceptance of sedative administration; memory of intraoperative events; the child's stress; adverse events; the child's pain during the procedure; the parent's, dentists', and child's perceptions of sedation; and economic analysis. Measures will be taken at baseline and drug administration and during and after the dental procedure. The necessary sample size was estimated to be 84 children after a blinded interim analysis of the first 30 cases.DiscussionThis study will provide data that can substantially add to science and pediatric dentistry as it examines the effect of sedative regimes from different perspectives (outcomes).Trial registrationClinicalTrials.gov, identifier: NCT02447289 . Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."

Project description:PurposeThe 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 methodsChildren 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 < 0.05, IBM SPSS).ResultsParticipants were 84 children (28 per group; 43 boys), with a mean age of 3.1 years (SD 1.2). Children's baseline and the dental sedation session characteristics were balanced among groups. The success of the treatment as assessed by the dichotomous variable 'quiet behavior for at least 60% of the session length' was: KMIN 50.0% (n = 14; OR 2.10, 95% CI 0.71 to 6.30), KMO 46.4% (n = 13; OR 1.80, 95% CI 0.62 to 5.40), MO 32.1% (n = 9) (P = 0.360). Adverse events were minor, occurred in 37 of 84 children (44.0%), and did not differ among groups (P = 0.462).ConclusionAll three regimens provided moderate dental sedation with minor adverse events, with marked variability in the behavior of children during dental treatment. The potential benefit of the ketamine-midazolam combination should be further investigated in studies with larger samples.Trial registrationClinicalTrials.gov, identifier: NCT02447289. Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."

Dataset Information

Comparison of nitrous oxide/midazolam and nitrous oxide/promethazine for pediatric dental sedation: A randomized, cross-over, clinical trial.

Publications

Comparison of nitrous oxide/midazolam and nitrous oxide/promethazine for pediatric dental sedation: A randomized, cross-over, clinical trial.

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