title: [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).
  
  
  CONCLUSIONS
  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.
authors: Department of Anesthesiology, Chinese Academy of Medical Sciences, Beijing, China.
authors: Hong
authors: H
authors: Zhao
authors: Tie-hu
authors: TH
authors: Ye
authors: Zhi-yi
authors: ZY
authors: Gong
mesh_terms: D000328:Adult; D000368:Aged; D016058:Analgesia, Patient-Controlled / Q000379:methods*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*; D010894:Piroxicam / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010894:Piroxicam; C059451:lornoxicam; D005283:Fentanyl