A comparison of the efficacy and safety of intranasal sufentanil/midazolam and ketamine/midazolam for sedation and analgesia in a paediatric population undergoing multiple dental extractions
De La Harpe, Charl Jacques
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This study was designed to evaluate the efficacy and safety of intranasal sufentanil/midazolam [S/M] and ketamine/madazolam [K/M] for sedation and analgesia in preschool children that require dental surgery [extractions]. Fifty children [ASA 1] aged 5 – 7 years, requiring six or more dental extractions under general anaesthesia, were allocated to two groups of 25 children to receive either ketamine 5 mg/kg or sufentanil 20μg intranasally, 20 minutes before induction of surgery in this randomised double-blind study. All the children in both groups in addition concurrently received nasal midazolam 0,3 mg/kg. For induction of anaesthesia, sevoflurane in nitrous oxide and oxygen, was used. S/M was accepted significantly better as a nasal pre-medication [p<0.05]. Both groups were equally sedated and a smooth mask induction of anaesthesia was experienced in the majority of children. Recovery of children in both groups were similar; 82% of the S/M group were fully recovered 120 minutes post-operatively versus 80% in the K/M group [p>0,05]. Effective postoperative analgesia for multiple extractions was provided. For pain evaluation, children were divided into two groups, a non-responder group where all pain values over time were more than 40 and a responder group where pain values were equal to, or less than 40. Seventy two percent of children in the S/M group were responders as to fifty two percent in the K/M group [p>0,05]. No adverse respiratory, cardiovascular or other effects were recorded. This study showed that intranasal administration of sufentanil /midazolam or ketamine/midazolam, provides safe and effective sedation and analgesia in children aged 5–7 years undergoing multiple dental extractions.