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A randomized double-blinded trial of chloral hydrate with or without hydroxyzine versus placebo for pediatric dental sedation
Costa, Luciane Ribeiro de Rezende Sucasas da; Costa, Paulo Sérgio Sucasas da; Lima, Alessandra Rodrigues de Almeida.
  • Costa, Luciane Ribeiro de Rezende Sucasas da; Federal University of Goiás. School of Dentistry. Department of Pediatric Dentistry. Goiânia. BR
  • Costa, Paulo Sérgio Sucasas da; Federal University of Goiás. School of Medicine. Department of Pediatrics. Goiânia. BR
  • Lima, Alessandra Rodrigues de Almeida; Health Department. Goiânia. BR
Braz. dent. j ; 18(4): 334-340, 2007. tab, graf
Article in English | LILACS | ID: lil-474475
ABSTRACT
Chloral hydrate and hydroxyzine are a drug combination frequently used by practitioners to sedate pediatric dental patients, but their effectiveness has not been compared to a negative control group in humans. The aim of this crossover, double-blinded study was to evaluate the effect of these drugs compared to a placebo, administered to young children for dental treatment. Thirty-five dental sedation sessions were carried out on 12 uncooperative ASA I children aged less than 5 years old. In each session patients were randomly assigned to groups P (placebo), CH (chloral hydrate 75 mg/kg) and CHH (chloral hydrate 50 mg/kg plus hydroxyzine 2.0 mg/kg). Vital signs and behavioral variables were evaluated every 15 min. Comparisons were statistically analyzed using Friedman and Wilcoxon tests. P, CH and CHH had no differences concerning vital signs, except for breathing rate. All vital signs were in the normal range. CH and CHH promoted more sleep in the first 30 min of treatment. Overall behavior was better in CH and CHH than in P. CH, CHH and P were effective in 62.5 percent, 61.5 percent and 11.1 percent of the cases, respectively. Chloral hydrate was safe and relatively effective, causing more satisfactory behavioral and physiological outcomes than a placebo.
RESUMO
A associação hidrato de cloral- hidroxizina tem sido utilizada na clínica odontológica para sedar crianças, mas sua efetividade ainda não foi comparada a um controle negativo em humanos. O objetivo deste estudo prospectivo foi avaliar o efeito dessas drogas, comparadas a um placebo, em crianças submetidas a tratamento odontológico. Trinta e cinco sessões de sedação foram realizadas em 12 crianças menores de 5 anos, não cooperativas, ASA classe I. Em cada sessão os pacientes foram aleatoriamente alocados para os grupos P (placebo), CH (hidrato de cloral 75 mg/kg) e CHH (hidrato de cloral 50 mg/kg mais hidroxizina 2,0 mg/kg). Sinais vitais e comportamento foram avaliados a cada 15 min, e comparados pelos testes de Friedman e Wilcoxon. Os grupos não apresentaram diferenças quanto às variáveis fisiológicas, exceto a freqüência respiratória. Todos sinais vitais registrados estiveram dentro de faixa aceitável. CH e CHH promoveram mais sono nos primeiros 30 min de tratamento. O comportamento geral foi melhor em CH e CHH do que em P. CH, CHH e P foram efetivos em 62,5 por cento, 61,5 por cento e 11,1 por cento dos casos, respectivamente. O hidrato de cloral foi seguro e relativamente efetivo, levando a resultados fisiológicos e comportamentais melhores que o placebo.
Subject(s)

Full text: Available Index: LILACS (Americas) Main subject: Chloral Hydrate / Conscious Sedation / Hydroxyzine / Hypnotics and Sedatives / Anesthesia, Dental Type of study: Controlled clinical trial / Observational study Limits: Child, preschool / Humans Language: English Journal: Braz. dent. j Journal subject: Dentistry Year: 2007 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Goiás/BR / Health Department/BR

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Full text: Available Index: LILACS (Americas) Main subject: Chloral Hydrate / Conscious Sedation / Hydroxyzine / Hypnotics and Sedatives / Anesthesia, Dental Type of study: Controlled clinical trial / Observational study Limits: Child, preschool / Humans Language: English Journal: Braz. dent. j Journal subject: Dentistry Year: 2007 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Goiás/BR / Health Department/BR