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A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02375191
Enrollment
58
Registered
2015-03-02
Start date
2015-01-31
Completion date
2016-06-30
Last updated
2016-08-17

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

Conditions

Congenital Skelectal Anomaly

Brief summary

The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery

Interventions

DRUGfentanyl
DRUGdexmedetomidine
DRUGRopivacaine

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* pediatric patients aged from 3 to 12 years undergoing orthopedic mechanical correction surgery

Exclusion criteria

* coagulopathy, refusal (parents), current infection on the lumbar area, spinal tract pathology

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain scoreDuring 48 hrs after pediatric orthopedic surgeryCHEOPS, FLACC score were measured

Countries

South Korea

Outcome results

None listed

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