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The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813018
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Management of postoperative pain is critical in the pediatric patients, however, safe and effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia is based on preventing a prolonged change in central nervous system function by blocking afferent input before the surgical stimulation may evoke central sensitization and aggravate amplification and prolongation of postoperative pain. However, the clinical efficacy of preemptive analgesia is still controversial. In this study, the investigators aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for corrective osteotomy of the lower extremities expecting severe postoperative pain.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Actual Study Start Date : July 7, 2016
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : July 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. FLACC scale score (Face, Legs, Activity, Cry, Consolability) [ Time Frame: 0-6 hours after the operation ]


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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities
  • ASA class I and II

Exclusion Criteria:

  • Coagulopathy
  • Neurological disease
  • Allergy to local anesthetics or contraindication to use of ropivacaine
  • Infection at the site of epidural catheter insertion

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Yonsei University
Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02813018    
Other Study ID Numbers: 4-2016-0322
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yonsei University:
child
analgesia
epidural
pain
postoperative
orthopedics
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents