Intranasal Dexmedetomidine Compared to a Combination of Intranasal Dexmedetomidine with Ketamine for Sedation of Children Requiring Dental Treatment: A Randomized Clinical Trial.

Outpatient pediatric sedation is challenging. This study aimed to test intranasal dexmedetomidine efficacy as a single drug or combined with ketamine (DK) to sedate children undergoing dental treatment. Children < 7 years were randomized into dexmedetomidine 2 mcg/kg and ketamine 1 mg/kg (DK) or dexmedetomidine 2.5 mcg/kg (D) groups. Videos from the dental sedation allowed the systematic assessment of children's behavior (primary outcome) according to the Ohio State University Behavioral Rating Scale (OSUBRS). Secondary outcomes were parental and dentist satisfaction, adverse events, and recovery time. The data were analyzed descriptively and through regression models. Participants were 88 children (44 per group; 50 boys). The duration of quiet behavior (OSUBRS) was higher than 50% (DK mean 58.4 [standard deviation 38.1]; D 55.2 [39.1]; p = 0.225). Parents (DK 78.0 [32.2]; D 72.7 [35.1]; p = 0.203) and dentists (KD 62.7 [41.0]; D 62.8 [40.1]; p = 0.339) were overall satisfied. Adverse events occurred in 16 cases (DK n = 10, 62.5%; D n= 6, 37.5%; p = 0.104) and were minor. The median recovery time in the DK group was 1.3 times greater than in group D (p < 0.05). Intranasal sedation with dexmedetomidine alone is equally efficacious and satisfactory for pediatric sedation with fewer adverse events and faster recovery than the DK combination.

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

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 < 0.05, IBM SPSS). RESULTS: Participants 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). CONCLUSION: All 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 REGISTRATION: ClinicalTrials.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)."

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

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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: ClinicalTrials.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)."

Does sevoflurane add to outpatient procedural sedation in children? A randomised clinical trial.

BACKGROUND: There is little evidence concerning the effect of sevoflurane in outpatient procedural sedation, especially in children. We hypothesised that the addition of sevoflurane to a sedation regimen improves children's behaviour with minimal adverse events. METHODS: This is a randomised, triple-blind clinical trial conducted on an outpatient basis. Participants were 27 healthy children aged 4 to 6 years, who previously refused dental treatment with non-pharmacologic methods. All participants received oral midazolam (0.5 mg/kg, maximum 20 mg) and oral ketamine (3 mg/kg, maximum 50 mg) and, in addition: Group MK - 100% oxygen; Group MKS - inhalational sevoflurane at a sedative dose (final expired concentration between 0.3 and 0.4%). Dental appointments were video recorded for assessment of the children's sleep patterns, crying, movements, and overall behaviour during the procedure with the Houpt scale. Intra- and post-operative adverse events were systematically reported. Data were analysed by bivariate analyses in the IBM SPSS v. 19, at a significance level of 5%. RESULTS: MK (n = 13) and MKS (n = 14) did not differ regarding the Houpt scores (P > 0.05), but 53.8% of children in the MK group showed hysterical and continuous crying at the time of the local anaesthesia injection, compared to 7.1% of children in the MKS group (P = 0.01; phi = 0.5). There was a trend toward less crying and movement over time during the dental appointment in the MKS group (P = 0.48). Minor adverse events were observed in 10 MK children and 4 MKS children (P = 0.01). CONCLUSIONS: The addition of sevoflurane to oral midazolam-ketamine improved the children's crying behaviour during local anaesthetic administration, and did not increase the occurrence of adverse events. TRIAL REGISTRATION: Clinical Trials NCT02284204 . Registered 5 October 2014.

Evaluation of quality of life of patients with sickle cell disease in a General Hospital of Goiás, Brazil

INTRODUÇÃO: A doença falciforme é a doença hereditária mais frequente no nosso país. O portador apresenta acometimentos físico, emocional e social, e sua qualidade de vida pode estar comprometida. OBJETIVO: Avaliar a qualidade de vida dos doentes falciformes em tratamento no Hospital das Clínicas da Universidade de Goiás. MÉTODO: Foram entrevistados 60 sujeitos entre 14 e 60 anos, doentes falciformes, em tratamento no Hospital das Clínicas. Aplicou-se o WHOQOL-Bref (instrumento avaliativo de qualidade de vida da Organização Mundial de Saúde - OMS), o questionário étnico-racial e o sociodemográfico. A significância foi definida por um erro padrão de 5 por cento (p < 0,05). Os sujeitos eram do sexo feminino em 53,3 por cento e solteiros em 71,7 por cento. A média da idade foi de 27 anos e o nível educacional até o primeiro grau completo foi de 51,7 por cento. RESULTADOS: A maioria considerou-se parda (46,7 por cento) e a minoria, negra (11,7 por cento). Apenas 6,7 por cento disseram ser vítimas de preconceito devido à cor e 33,3 por cento disseram ser vítimas de preconceito devido à doença. Os sujeitos relataram ligação entre doença e sua cor em 48,3 por cento. A qualidade de vida foi avaliada negativa em 6,7 por cento e, em 70 por cento, positiva. Apresentaram satisfação negativa quanto à saúde 23,3 por cento dos sujeitos e, em 48,3 por cento, a satisfação foi positiva. Os escores do WHOQOL-Bref, de 0 a 100 foram: domínio físico (57,32), psicológico (66,03), social (69,86) e ambiental (52,76). CONCLUSÃO: Houve correlação significativa entre preconceito devido à doença e nível educacional, e entre idade e todos os domínios. A doença falciforme limita a vida do portador, com comprometimento da qualidade de vida. A doença está perdendo o caráter de "black related disease", coincidindo com a miscigenação racial brasileira.

INTRODUCTION: Sickle cell disease is the most common inherited disease in Brazil. Patients are known to suffer physical, emotional and social impairment and their quality of life may well be involved. METHOD: The quality of life of sickle cell disease patients treated in Hospital das Clínicas of the Universidade Federal de Goiás was evaluated. Sixty patients with ages ranging from 14 to 60 years old were interviewed. The WHOQOL-Bref (a quality of life validation instrument of the World Health Organization), and the ethnical-racial, and sociodemographic questionnaires were administered. A standard error of 5 percent (p-value < 0.05) was considered acceptable. RESULTS: The mean age of the participants was 27 years old, 53.3 percent of the patients were women, 71.7 percent were single and 51.7 percent had completed elementary school. The majority classified themselves as mulattos (46.7 percent) and the minority Blacks (11.7 percent). Only 6.7 percent considered themselves victims of racial discrimination because of their skin color but 33.3 percent considered themselves victims of discrimination due to sickle cell disease. The patients 48.3 percent reported an association between their disease and their skin color. The quality of life was considered bad by 6.7 percent and good by 70 percent. A total of 48.3 percent considered their lives to be satisfactory and 23.3 percent to be unsatisfactory. The scores obtained from the WHOQOL-Bref (from 0 to 100) were: 57.32 for physical, 66.03 for psychological, 69.86 for social and 52.76 for environmental domains. There were significant correlations of discrimination due to the disease with educational level and age with all the WHOQOL-Bref domains. CONCLUSION: Sickle cell disease significantly limits the quality of life of patients. Also, sickle cell disease, coinciding with the racial miscegenation, is losing its "black-related disease" character in Brazil.