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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial

Trials > Ausgabe 1/2017
Heloisa Sousa Gomes, Analya Rodrigues Miranda, Karolline Alves Viana, Aline Carvalho Batista, Paulo Sucasas Costa, Anelise Daher, Geovanna de Castro Morais Machado, Joji Sado-Filho, Liliani Aires Candido Vieira, Patrícia Corrêa-Faria, Marie Therese Hosey, Luciane Rezende Costa
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Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1919-2) contains supplementary material, which is available to authorized users.



Uncooperative 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.


We 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.


This 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 registration, identifier: NCT02447289. Registered on 11 May 2015, named “Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO).”
Additional file 1: World Health Organization Trial Registration Data Set. (PDF 80 kb)
Additional file 2: Consent Forms applied to parents and pediatric dentists (in Portuguese). (PDF 185 kb)
Additional file 3: SPIRIT 2013 Checklist for the NASO study protocol. (DOC 104 kb)
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