Comparison of efficacy of flurbiprofen axetil combined with fentanyl administered using different modes for postoperative analgesia: a prospective, multicenter, randomized, double-blind, control, parallel-group study / 中华麻醉学杂志

ABSTRACT

Objective To compare the efficacy of flurbiprofen axetil combined with fentanyl administered using different modes for postoperative analgesia.Methods This was a prospective,multicenter,randomized,double-blind,control,parallel-group study.ASA Ⅰ or Ⅱ patients,aged 14-91 yr,weighing 35-95 kg,scheduled for orthopedic,thoracic or hepatobiliary surgery under general anesthesia from January 2010 to October 2010,were randomly divided into A,B and C groups.The three groups received patient-controlled intravenous analgesia (PCIA) after surgery.In group A,flurbiprofen axetil 100 mg was injected immediately after the end of surgery and then PCIA was performed with fentanyl 1.0 mg in 100 ml of normal saline.In group B,PCIA was performed with flurbiprofen axetil 200 mg and fentanyl 0.6 mg in 100 ml of normal saline.In group C,flurbiprofen axetil 100 mg was injected immediately after the end of surgery and then PCIA was performed with flurbiprofen axetil 200 mg and fentanyl 0.6 mg in 100 ml of normal saline.The PCA pump was set up with a 2 ml bolus dose,a 10 min lockout interval and background infusion at a rate of 2 ml/h.VAS scores at rest and during activity and sedation score were recorded at the end of surgery and 4,8 and 24 h after surgery.The effective analgesia,excessive sedation,nausea and vomiting,dizziness,somnolence and respiratory depression were recorded within 24 h after surgery.Samples from the PCIA bump were taken to do microbe culture experiment at 24 and 48 h after surgery.Results Two thousand five hundred and ninety-six cases completed this trial (875 cases in group A,946 cases in group B and 775 cases in group C).Compared with group A,VAS scores at rest and during activity at the end of surgery and 4,8 and 24 h after surgery and sedation score were significantly decreased in group B,VAS scores at rest and during activity were significantly decreased at the end of surgery and 4 and 8 h after surgery and sedation scores were significantly increased at 4 and 8 h after surgery in group C,the rate of effective analgesia was increased in groups B and C,the incidence of excessive sedation was decreased in group B,while increased in group C,the incidence of postoperative nausea and vomiting was significantly decreased in groups B and C,and the incidence of postoperative dizziness was significantly decreased in group C (P ＜ 0.05).Compared with group B,no significant change was found in the VAS scores at rest and during activity,rate of effective analgesia,and incidences of nausea and vomiting,and somnolence (P ＞ 0.05),sedation scores were significantly increased at the end of operation and 4 and 8 h after surgery,the incidence of excessive sedation was increased,and the incidence of postoperative dizziness was decreased in group C (P ＜ 0.05).Neither bacterium nor fungus was found in the PCIA pump samples.Conclusion PCIA with flurbiprofen axetil 200 mg and fentanyl 0.6 mg (background infusion at a rate of 2 ml/h,2 ml bolus dose,10 min lockout interval) provides better efficacy and the occurrence of sides effects is low for the patients undergoing moderate or major operations.