A randomized, controlled, crossover trial of oral midazolam and hydroxyzine for pediatric dental sedation

Abstract

ABSTRACT: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. DESCRIPTORS: Conscious sedation; Hydroxyzine; Pediatric dentistry. RESUMO:Há controvérsias quanto aos benefícios do midazolam na sedação de crianças durante a atenção odontológi-ca. Conduziu-se um ensaio clínico controlado, cruzado e duplo-cego para comparar o efeito sedativo em Odontopediatria da administração oral do midazolam, associado ou não à hidroxizina. Trinta e sete sessões foram realizadas em 11 crianças menores de cinco anos, ASA I. Em cada atendimento, os pacientes receberam aleatoriamente o medicamento conforme os grupos: P -placebo, M -midazolam (1,0 mg/kg); MH -midazolam (0,75 mg/kg) associado à hidroxizina (2,0 mg/kg). Os sinais vitais (pressão arterial, freqüência respiratória, pulso e saturação de oxigênio) e os parâmetros comportamentais (consciência, choro, movimento, comportamento geral) foram avaliados a cada 15 minutos. As comparações entre grupos e entre momentos de atendimento num mesmo grupo foram estabelecidas estatisticamente através dos testes Friedman e Wilcoxon. Os grupos P, M e MH não diferiram quanto aos sinais vitais, os quais se mantiveram dentro de valores aceitáveis. A freqüência cardíaca aumentou nos grupos P e M com o transcorrer da sessão. O grupo M esteve associado a menos choro e movimento nos primeiros 15 minutos de tratamento. O grupo MH apresentou mais sonolência no início da sessão. O comportamento geral foi melhor em M do que em P e MH. M produziu sedação efetiva em 77% dos casos, e MH em 30,8%. Concluiu-se que o midazolam foi efetivo e seguro, e que sua associação à hidroxizina não repercutiu em vantagens adicionais na sedação odontopediátrica.

Mothers' perceptions about pediatric dental sedation as an alternative to dental general anesthesia

“…Moderate sedation associated with protective stabilization is an alternative to general anesthesia 7 . Protective stabilization is necessary during pediatric dental sedation in 50-94% of cases [24][25] . Unexpectedly, protective stabilization of a fully conscious child did not cause any distress for the caregiver in the present study.…”

Safety of oral midazolam sedation use in paediatric dentistry: a review

“…There were no RCTs found looking at side effects alone. After combining the results from Medline and Embase searches and removing papers that did not meet the criteria, 16 papers were included [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] . Data from these papers are summarised in Table 1.…”

Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database

“…Among the latter, only two studies 58,63 used complete control over selection bias, through concomitantly using randomization and allocation sequence concealment. Lima et al, 50 Ozaki et al, 58 Salgado et al, 73 Bortolluzy et al, 16 Costa et al,et al 56 and Peruzzo et al 63 used central randomization by third parties, or sequentially numbered envelopes or packages containing medications or the test and control substances. Guimarães et al 47 used opaque sealed envelopes.…”

“…One study 46 reported a triple blind method, while nine studies reported a double-blind method: de Assis et al, 32 Bortolluzy et al, 16 Botelho et al, 17 Calvo et al, 19 Faraco et al, 36 Guimarães et al, 47 Kogawa et al, 48 Rivera et al 68 and Vieira et al 86 Fifteen studies reported single blinding of the healthcare providers or outcome assessors. 10,23,25,27,28,30,31,33,37,39,44,46,50,58 In another 14 studies, the authors reported blinding but did not describe the method, or blinding was impossible. The studies by Gispert Abreu et al 41 and Gispert Abreu et al 42 were examples of the impossibility of blinding, because there was no report of any alternative treatment or placebo for the controls.…”