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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02813018

Enrollment

Registered

2016-06-24

Start date

2016-07-07

Completion date

2017-07-15

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Surgical Patients, Preemptive Epidural Analgesia

Keywords

child, analgesia, epidural, pain, postoperative, orthopedics

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.

Interventions

PROCEDURE0.2 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.

PROCEDURE0.2mg/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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
FLACC scale score (Face, Legs, Activity, Cry, Consolability)	0-6 hours after the operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026