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

Hugo Sérgio de Oliveira Gomes, Heloisa de Sousa Gomes, Joji Sado-Filho, Luciane Rezende Costa, Paulo Sucasas Costa, Hugo Sérgio de Oliveira Gomes, Heloisa de Sousa Gomes, Joji Sado-Filho, Luciane Rezende Costa, Paulo Sucasas Costa

Abstract

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.

Keywords: Anti-anxiety agents; Child behaviour; Conscious sedation; Dental anxiety; Dental care for children; Drug-related side effects and adverse reactions; Ketamine; Midazolam; Pain management; Sevoflurane.

Figures

Fig. 1
Fig. 1
Sedation of children for dental treatment with sevoflurane provided through a nasal mask (a) and assessed by an anaesthetic gas analyser (b). Consents to publish this image were collected from the child’s parents and health professionals
Fig. 2
Fig. 2
Flow diagram of the progress through the clinical trial phases
Fig. 3
Fig. 3
Behaviour scores according to Houpt scales comparing groups midazolam/ketamine (MK) and midazolam/ketamine/sevoflurane (MKS) (P > 0.05; Mann-Whitney test)
Fig. 4
Fig. 4
Houpt scores for “Movement” and “Cry” during the dental treatment sessions under sedation, according to the midazolam/ketamine (MK) and midazolam/ketamine/sevoflurane (MKS) group

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Source: PubMed

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