Xiuze Li1, Mengjun Zhou, Qing Xia, Wei Li, Yonghong Zhang. 1. From the Department of Anaesthesiology (XZL, QX, WL, YHZ) and Department of Health Statistics (MJZ), Mianyang Central Hospital, Sichuan, China.
Abstract
BACKGROUND:Postoperative shivering is one of the most common complications in patients recovering from general anaesthesia. Although a variety of pharmacological therapies have been used to control postoperative shivering, no ideal drug has been found to date. OBJECTIVES: The aim of this study was to compare the efficacy and accompanying side-effects of prophylactic parecoxib sodium with that of tramadol or placebo for the prevention of postoperative shivering. DESIGN: A randomised, double-blind clinical study. SETTING: Mianyang Central Hospital, Sichuan, China, from December 2011 to November 2012. PATIENTS: One hundred and twenty adult patients, ASA 1 or 2, aged 20 to 60 years and scheduled for elective abdominal surgery under general anaesthesia. Reasons for noninclusion included allergy to any of the medications used; severe cardiovascular disease; kidney or liver dysfunction; peptic ulcer; muscle disease; intraoperative blood or blood products transfusion; or a history of convulsions or fever. INTERVENTIONS: The patients were allocated randomly to receive parecoxib sodium 40 mg (Group P, n = 40), tramadol 2 mg kg (Group T, n = 40) or isotonic saline (Group S, n = 40) 30 min before the end of surgery. MAIN OUTCOME MEASURES: The primary outcome measure was the incidence of postoperative shivering. Secondary outcomes were scores for postoperative pain and sedation, and the incidence of postoperative nausea and vomiting. RESULTS: The incidence and severity of postoperative shivering were significantly lower in Groups P and T than in Group S (P < 0.001). The sedation scores were higher in Group T than in Groups P and S (P < 0.05). The incidence of postoperative nausea and vomiting was also significantly higher in Group T than in Groups P and S (P = 0.016). CONCLUSION: Intravenous injection of parecoxib sodium 40 mg before the end of surgery effectively reduces the occurrence and severity of postoperative shivering after general anaesthesia without significant side effects. TRIAL REGISTRATION: ChiCTR-TRC-12002870.
RCT Entities:
BACKGROUND: Postoperative shivering is one of the most common complications in patients recovering from general anaesthesia. Although a variety of pharmacological therapies have been used to control postoperative shivering, no ideal drug has been found to date. OBJECTIVES: The aim of this study was to compare the efficacy and accompanying side-effects of prophylactic parecoxib sodium with that of tramadol or placebo for the prevention of postoperative shivering. DESIGN: A randomised, double-blind clinical study. SETTING: Mianyang Central Hospital, Sichuan, China, from December 2011 to November 2012. PATIENTS: One hundred and twenty adult patients, ASA 1 or 2, aged 20 to 60 years and scheduled for elective abdominal surgery under general anaesthesia. Reasons for noninclusion included allergy to any of the medications used; severe cardiovascular disease; kidney or liver dysfunction; peptic ulcer; muscle disease; intraoperative blood or blood products transfusion; or a history of convulsions or fever. INTERVENTIONS: The patients were allocated randomly to receive parecoxib sodium 40 mg (Group P, n = 40), tramadol 2 mg kg (Group T, n = 40) or isotonic saline (Group S, n = 40) 30 min before the end of surgery. MAIN OUTCOME MEASURES: The primary outcome measure was the incidence of postoperative shivering. Secondary outcomes were scores for postoperative pain and sedation, and the incidence of postoperative nausea and vomiting. RESULTS: The incidence and severity of postoperative shivering were significantly lower in Groups P and T than in Group S (P < 0.001). The sedation scores were higher in Group T than in Groups P and S (P < 0.05). The incidence of postoperative nausea and vomiting was also significantly higher in Group T than in Groups P and S (P = 0.016). CONCLUSION: Intravenous injection of parecoxib sodium 40 mg before the end of surgery effectively reduces the occurrence and severity of postoperative shivering after general anaesthesia without significant side effects. TRIAL REGISTRATION: ChiCTR-TRC-12002870.