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

NCT02813018 | Completed

• 1 other identifier: 4-2016-0322
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Surgical Patients; Preemptive Epidural Analgesia

Keywords

child; analgesia; epidural; pain; postoperative; orthopedics

Outcome Measures

Primary Outcomes (1)

• FLACC scale score (Face, Legs, Activity, Cry, Consolability)

  0-6 hours after the operation

Study Arms (2)

preemptive group

EXPERIMENTAL

Group who will be received ropivacaine bolus and continous infusion 5 minutes before skin incision.

Procedure: 0.2 ml/kg of 0.2% ropivacaine

saline group

PLACEBO COMPARATOR

Group who will be received saline bolus and continous infusion 5 minutes before skin incision

Procedure: 0.2mg/kg of Normal Saline

Interventions

0.2 ml/kg of 0.2% ropivacaine PROCEDURE

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.

preemptive group

0.2mg/kg of Normal Saline PROCEDURE

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.

saline group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.

  PMID: 15710025 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 24, 2016
• Study Start: July 7, 2016
• Primary Completion: July 15, 2017
• Study Completion: July 15, 2017
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

KR (1)