[Non-inferiority study of lornoxicam to patient-controlled analgesia in patients after hysterectomy].

ABSTRACT

OBJECTIVE: To evaluate the non-inferiority of lornoxicam to fentanyl in patient-controlled intravenous analgesia after hysterectomy. METHODS: In this prospective randomized controlled study, 117 patients who suffered from moderate to severe pain i.e. pain visual analogue scale (VAS) ≥4 after hysterectomy were allocated to receive lornoxicam (Group L) or fentanyl (Group F) for patient-controlled analgesia. The patients were given a loading dose of lornoxicam 4 mg or fentanyl 50 µg after the enrollment according to the patients' grouping and connected to the patient-controlled analgesia device containing lornoxicam 0.4 g/L or fentanyl 5 mg/L with bolus dose set at 2.5 mL and lockout interval set at 10 min. Pain scores were rated using VAS at 6, 12, and 24 h postoperatively. Pain intensity difference (PID) was the difference between pain scores rated immediately after surgery and 6, 12 and 24 h postoperatively. The sum of pain intensity difference over 24 h (SPID-24) was the sum of PID at 6, 12 and 24 h. non-inferiority could be claimed if the lower limit of the 95% confidence interval (CI) for SPID-24 difference between the two groups was greater than pre-specified non-inferiority margin -3. RESULTS: No difference was detected for pain scores at any time point between the two groups. SPID-24 were 12.0±6.1 and 10.2±5.4 (P>0.05). SPID-24 difference between the two groups was 0.66, 95%CI -1.24 to 2.56, and the lower limit greater than non-inferiority margin -3. Adverse effects, such as nausea, vomiting, and drowsiness were significantly less in lornoxicam group than in fentanyl group (P<0.05). CONCLUSION: Lornoxicam is not inferior to the equivalent dose of fentanyl with regard to the margin pre-specified at -3 in reducing moderate to severe postoperative pain after hysterectomy.