OBJECTIVE This randomized, double-blinded clinical study was designed to compare the efficacy and safety of remifentanil and morphine administered using intravenous (i.v.) patient-controlled analgesia (PCA) for postoperative analgesia after major abdominal surgery during the first 24 postoperative hours. METHODS Sixty-nine patients were randomly allocated into two groups, each receiving remifentanil or morphine. The first group received i.v. remifentanil PCA with a loading dose of 45 microg, a maintenance dose of 1 microg min(-1), a bolus dose of 15 microg and a lockout interval of 10 min during the first 24 postoperative hours. The second group received i.v. morphine PCA with a loading dose of 5 mg, a maintenance dose of 0.3 mg h(-1), a bolus dose of 1 mg and a lockout interval of 15 min. Age, weight, sex, history of general anaesthesia, duration of surgery and time spent in the post-anaesthesia care unit were recorded. Preoperative pulse rate, systolic and diastolic blood pressures (BP), respiration rate and arterial blood gases were collected. Pulmonary function was tested before induction of anaesthesia, as well as at 4 and 26 h after operation. Pulse rate, systolic and diastolic BP, respiration rate, arterial blood gases, sedation and visual analogue scores, and presence of side-effects in the recovery room and on the ward for 24 h were recorded at 0, 1, 2, 4, 6, 12, 18 and 24 h after operation. Total drug use, number of boluses delivered, number of boluses demanded and delivery/demand ratio were collected. RESULTS Sixty patients were evaluated. The groups did not differ in age, weight, sex, history of general anaesthesia, duration of surgery or time spent in the recovery unit. There were also no clinically relevant differences between the groups with regard to haemodynamic and respiratory parameters as well as sedation and visual analogue scores (P > 0.05). More bolus doses were demanded and delivered and the delivery/demand ratio was significantly higher in the remifentanil group (P < 0.05). There was no finding suggesting acute opioid tolerance during remifentanil or morphine PCA. CONCLUSIONS The i.v. remifentanil PCA with the chosen dosage regimen after abdominal surgery produces postoperative analgesia and has cardiovascular side-effects similar to those achieved with i.v. morphine. Special attention must be given to respiratory depression during establishment of PCA with remifentanil.