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



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%.



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).



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.



Clinical Trials NCT02284204 . Registered 5 October 2014.
Universidade Federal de Goiás, Goiânia, Brazil.
Hugo Sérgio de Oliveira
HS
Gomes
Dentistry Graduate Program, Universidade Federal de Goiás, Goiânia, Brazil.
Heloisa de Sousa
HS
Gomes
University Hospital, Universidade Federal de Goiás, Goiânia, Brazil.
Joji
J
Sado-Filho
Faculty of Dentistry, Universidade Federal de Goiás, Goiânia, Brazil.
Luciane Rezende
LR
Costa
Department of Paediatrics, Universidade Federal de Goiás, Faculdade de Medicina, Rua 235 com Primeira Avenida, sem número, Setor Universitário, Goiânia, CEP 74605-020, Brazil. paulosucasas@ufg.br.
Paulo Sucasas
PS
Costa
D000284:Administration, Oral; D000553:Ambulatory Care / Q000379:methods*; D000778:Anesthetics, Dissociative; D018685:Anesthetics, Inhalation; D000779:Anesthetics, Local; D002648:Child; D002652:Child Behavior; D002675:Child, Preschool; D016292:Procedural Sedation / Q000379:methods*; D003448:Crying; D019140:Dental Care for Children / Q000379:methods*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives; D007649:Ketamine; D008297:Male; D008738:Methyl Ethers; D008874:Midazolam; D017063:Outcome Assessment, Health Care; D000077149:Sevoflurane
D000778:Anesthetics, Dissociative; D018685:Anesthetics, Inhalation; D000779:Anesthetics, Local; D006993:Hypnotics and Sedatives; D008738:Methyl Ethers; D000077149:Sevoflurane; D007649:Ketamine; D008874:Midazolam
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