The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery
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|ClinicalTrials.gov Identifier: NCT02813018|
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Surgical Patients Preemptive Epidural Analgesia||Procedure: 0.2 ml/kg of 0.2% ropivacaine Procedure: 0.2mg/kg of Normal Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Actual Study Start Date :||July 7, 2016|
|Actual Primary Completion Date :||July 15, 2017|
|Actual Study Completion Date :||July 15, 2017|
Experimental: preemptive group
Group who will be received ropivacaine bolus and continous infusion 5 minutes before skin incision.
Procedure: 0.2 ml/kg of 0.2% ropivacaine
In the preemptive group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of 0.2% ropivacaine, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.
Placebo Comparator: saline group
Group who will be received saline bolus and continous infusion 5 minutes before skin incision
Procedure: 0.2mg/kg of Normal Saline
In the saline group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of normal saline, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.
- FLACC scale score (Face, Legs, Activity, Cry, Consolability) [ Time Frame: 0-6 hours after the operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813018
|Korea, Republic of|
|Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine|
|Seoul, Korea, Republic of, 120-752|