NCT02375191

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

February 24, 2015

Last Update Submit

August 16, 2016

Conditions

Congenital Skelectal Anomaly

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain score

    CHEOPS, FLACC score were measured

    During 48 hrs after pediatric orthopedic surgery

Study Arms (2)

fentanyl

ACTIVE COMPARATOR

0.2% ropivacaine+ 1 mcg/kg fentanyl

Drug: fentanylDrug: Ropivacaine

dexmedetomidine

EXPERIMENTAL

0.2% ropivacaine+1 mcg/kg dexmedetomidine

Drug: dexmedetomidineDrug: Ropivacaine

Interventions

fentanylDRUG
fentanyl
dexmedetomidineDRUG
dexmedetomidine
RopivacaineDRUG
dexmedetomidinefentanyl

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

FentanylDexmedetomidineRopivacaine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzolesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 2, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

KR(1)