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A randomized double-blinded trial of chloral hydrate with or without hydroxyzine versus placebo for pediatric dental sedation

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      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%, 61.5% and 11.1% of the cases, respectively. Chloral hydrate was safe and relatively effective, causing more satisfactory behavioral and physiological outcomes than a placebo.

      Translated abstract

      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%, 61,5% e 11,1% dos casos, respectivamente. O hidrato de cloral foi seguro e relativamente efetivo, levando a resultados fisiológicos e comportamentais melhores que o placebo.

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      Most cited references 16

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      Project USAP 2000--use of sedative agents by pediatric dentists: a 15-year follow-up survey.

       Milton Houpt (2015)
      A national survey of members of the American Academy of Pediatric Dentistry was conducted to provide a 15-year update of information regarding the use of sedative agents by pediatric dentists. All 3,315 active members of the Academy were sent questionnaires regarding the frequency of their use of sedation and 1,778 responded. Practitioners were questioned regarding their use of sedative agents and the nature of their patients receiving sedation. In addition, they were questioned in regard to their use of restraints and reasons for change in their use of sedation during the past two years. In regard to the use of nitrous oxide alone, 47% of practitioners responded that they use nitrous oxide less than 11% of the time. In regard to other types of sedative agents, most practitioners use little, if any, sedation. Eighty-two percent use sedation for less than 11% of their patients. Of the 1,778 respondents, 1,224 used drugs other than nitrous oxide. In a typical three-month period, they performed 77,112 sedations. Of that number, 61,662 (80%) were administered by only 478 practitioners who use sedation on the average of once or greater each day. In comparison with previous surveys in 1985, 1991 and 1995, these results demonstrate an overall increased use of sedation by pediatric dentists. However, the increased use is due primarily to an increase in the numbers of practitioners who are heavier users of sedation (once or greater each day).
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        A retrospective study of chloral hydrate, meperidine, hydroxyzine, and midazolam regimens used to sedate children for dental care.

         S. Wilson,  J. Easton,  K Lamb (2000)
        The purpose of this retrospective study was twofold: a) to examine the behavior and physiology of pre-school children each sedated with 1 of 3 drug regimens based on patient age, dental needs, and pre-operative clinical impression; and b) to determine the association between pre-operative behaviors to the behavior and physiology of the sedated children.
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          A randomized, controlled, crossover trial of oral midazolam and hydroxyzine for pediatric dental sedation

          The effectiveness of oral midazolam in pediatric dentistry is controversial. This randomized, controlled, crossover, double blind clinical trial was conducted in order to study the effect of midazolam, used either alone or in association with hydroxyzine, during child dental treatment. Thirty seven dental sedation sessions were carried out on 11 ASA I uncooperative children less than five years-old. In each appointment children were randomly assigned to groups: P - placebo, M - midazolam (1.0 mg/kg), or MH - midazolam (0.75 mg/kg) plus hydroxyzine (2.0 mg/kg). Vital signs (blood pressure, breathing rate, pulse and oxygen saturation) and behavior parameters (consciousness, crying, movement, overall behavior) were evaluated every 15 minutes. Friedman and Wilcoxon statistical tests were used to compare groups and different moments in the same group. Normal values of vital signs were usually registered. Heart rate increased in groups P and M as the session went on. Group M presented less crying and movement at the first 15 minutes of treatment. Group MH caused more drowsiness at the beginning of the session. Overall behavior was better in group M than in groups P or MH. Group M produced effective sedation in 77% of the cases, and group MH did so in 30.8%. It was concluded that midazolam was effective and safe, and its association with hydroxyzine did not lead to additional advantages in pediatric dental sedation.
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            Author and article information

            Affiliations
            [1 ] Universidade Federal de Goiás Brazil
            [2 ] Universidade Federal de Goiás Brazil
            [3 ] Health Department Brazil
            Contributors
            Role: ND
            Role: ND
            Role: ND
            Journal
            bdj
            Brazilian Dental Journal
            Braz. Dent. J.
            Fundação Odontológica de Ribeirão Preto (Ribeirão Preto )
            1806-4760
            2007
            : 18
            : 4
            : 334-340
            S0103-64402007000400012
            10.1590/S0103-64402007000400012

            http://creativecommons.org/licenses/by/4.0/

            Product
            Product Information: SciELO Brazil
            Categories
            DENTISTRY, ORAL SURGERY & MEDICINE

            Dentistry

            hydroxyzine, chloral hydrate, pediatric dentistry, conscious sedation

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