BACKGROUND: The use of cuffed tracheal tubes (TTs) in small children is still controversial. The aim of this study was to compare post-extubation morbidity and TT exchange rates when using cuffed vs uncuffed tubes in small children. METHODS: Patients aged from birth to 5 yr requiring general anaesthesia with TT intubation were included in 24 European paediatric anaesthesia centres. Patients were prospectively randomized into a cuffed TT group (Microcuff PET) and an uncuffed TT group (Mallinckrodt, Portex, Rüsch, Sheridan). Endpoints were incidence of post-extubation stridor and the number of TT exchanges to find an appropriate-sized tube. For cuffed TTs, minimal cuff pressure required to seal the airway was noted; maximal cuff pressure was limited at 20 cm H(2)O with a pressure release valve. Data are mean (SD). RESULTS: A total of 2246 children were studied (1119/1127 cuffed/uncuffed). The age was 1.93 (1.48) yr in the cuffed and 1.87 (1.45) yr in the uncuffed groups. Post-extubation stridor was noted in 4.4% of patients with cuffed and in 4.7% with uncuffed TTs (P=0.543). TT exchange rate was 2.1% in the cuffed and 30.8% in the uncuffed groups (P<0.0001). Minimal cuff pressure required to seal the trachea was 10.6 (4.3) cm H(2)O. CONCLUSIONS: The use of cuffed TTs in small children provides a reliably sealed airway at cuff pressures of <or=20 cm H(2)O, reduces the need for TT exchanges, and does not increase the risk for post-extubation stridor compared with uncuffed TTs.