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

NCT ID: NCT02375191

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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Conditions

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Congenital Skelectal Anomaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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fentanyl

0.2% ropivacaine+ 1 mcg/kg fentanyl

Group Type ACTIVE_COMPARATOR

fentanyl

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

dexmedetomidine

0.2% ropivacaine+1 mcg/kg dexmedetomidine

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Interventions

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fentanyl

Intervention Type DRUG

dexmedetomidine

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0921

Identifier Type: -

Identifier Source: org_study_id

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