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.