NCT02813018

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

Completed NA Last updated 20 June 2018

What this trial tests

NA trial testing 0.2 ml/kg of 0.2% ropivacaine in Pediatric Surgical Patients in 50 participants. Completed in 15 July 2017.

Timeline

7 July 2016

Primary endpoint
15 July 2017

15 July 2017

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	50
Start date	7 July 2016
Primary completion	15 July 2017
Estimated completion	15 July 2017
Sites	1 location across South Korea

Drugs / interventions tested

• 0.2 ml/kg of 0.2% ropivacaine
• 0.2mg/kg of Normal Saline

Conditions studied

• Pediatric Surgical Patients — all drugs for Pediatric Surgical Patients →
• Preemptive Epidural Analgesia — all drugs for Preemptive Epidural Analgesia →

Sponsor

Yonsei University

Who can join

Adults 3 to 12, any sex, with Pediatric Surgical Patients or Preemptive Epidural Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of preemptive analgesia on acute postoperative pain in children undergoing major orthopedic surgery of the lower extremities.
   Kim DH, Kim N, Lee JH, Jo M, et al · · 2018 · cited 4× · PMID 30288096 · DOI 10.2147/jpr.s175169