STUDY OBJECTIVE: To investigate the analgesic efficacy and safety of epidural infusion of clonidine in children undergoing major abdominal surgery. DESIGN: Randomized open-label study. SETTING:Postoperative anesthetic unit and pediatric ward of a metropolitan hospital. PATIENTS: Forty children aged 0 to 3 years undergoing major abdominal surgery. INTERVENTIONS: Children were randomly allocated to receive a 24-hour epidural infusion of clonidine 1 microg.mL(-1) at rate of 0.2 mL.kg -1.h -1 preceded by a bolus of 2 microg.kg -1 (CLON group) or a mixture of clonidine 1 microg.mL -1 and ropivacaine 0.1% at rate of 0.2 mL.kg -1.h -1. Both groups received intravenous (IV) ketoprofen 2 mg.kg -1 every 8 hours. Breakthrough pain was treated with IV tramadol 1 mg.kg(-1). MEASUREMENTS: Tramadol requirement, sedation and respiratory and hemodynamic changes were measured. MAIN RESULTS: Approximately 77% and 59.3% of the CLON and CLON+ROPIV groups, respectively, required no tramadol or only one dose over a 24-hour period. Except for those patients who exhibited frequent coughing during the night (4 and 5 patients in the CLON and CLON+ROPIV groups, respectively), no study patients required an analgesic and all had good sleep quality during the first night. Sedation and decreased systolic blood pressure were observed after the clonidine bolus was given. CONCLUSION: For children undergoing major abdominal surgery, the addition of epidural infusion of clonidine or clonidine plus ropivacaine to IV ketoprofen provided good analgesia quality for postoperative rest pain.
RCT Entities:
STUDY OBJECTIVE: To investigate the analgesic efficacy and safety of epidural infusion of clonidine in children undergoing major abdominal surgery. DESIGN: Randomized open-label study. SETTING: Postoperative anesthetic unit and pediatric ward of a metropolitan hospital. PATIENTS: Forty children aged 0 to 3 years undergoing major abdominal surgery. INTERVENTIONS:Children were randomly allocated to receive a 24-hour epidural infusion of clonidine 1 microg.mL(-1) at rate of 0.2 mL.kg -1.h -1 preceded by a bolus of 2 microg.kg -1 (CLON group) or a mixture of clonidine 1 microg.mL -1 and ropivacaine 0.1% at rate of 0.2 mL.kg -1.h -1. Both groups received intravenous (IV) ketoprofen 2 mg.kg -1 every 8 hours. Breakthrough pain was treated with IV tramadol 1 mg.kg(-1). MEASUREMENTS: Tramadol requirement, sedation and respiratory and hemodynamic changes were measured. MAIN RESULTS: Approximately 77% and 59.3% of the CLON and CLON+ROPIV groups, respectively, required no tramadol or only one dose over a 24-hour period. Except for those patients who exhibited frequent coughing during the night (4 and 5 patients in the CLON and CLON+ROPIV groups, respectively), no study patients required an analgesic and all had good sleep quality during the first night. Sedation and decreased systolic blood pressure were observed after the clonidine bolus was given. CONCLUSION: For children undergoing major abdominal surgery, the addition of epidural infusion of clonidine or clonidine plus ropivacaine to IV ketoprofen provided good analgesia quality for postoperative rest pain.