A comparison of oral transmucosal fentanyl and oral midazolam for premedication in children

Abstract

Oral transmucosal fentanyl citrate (OTF) was compared with midazolam as a premedicant in a prospective, randomised, placebo-controlled, double-blind trial. Eighty children (ASA grade 1 or 2, aged 3-9 years) who presented for tonsillectomy were randomly allocated to receive either 2.5 ml OTF (15-20 μg.kg-1) in a lollipop format and 0.5 ml.kg-1 placebo syrup, or midazolam syrup (0.5 mg.kg-1) and a placebo lollipop (2.5 ml). The acceptability of sedation, anxiety and compliance with anaesthetic induction were assessed. The children were given an 'emergence' score for their recovery. Analgesia requirements, the incidence of vomiting, itching and any behavioural changes were assessed for 6 h postoperatively. Oral transmucosal fentanyl citrate was as effective as midazolam in aiding compliance with anaesthesia, but is significantly better in its appeal to children (p < 0.001) and emergence (p < 0.001) characteristics. In conclusion, OTF may be particularly useful as a premedicant in paediatric practice.