ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

NCT ID: NCT01374737

Last Updated: 2011-06-16

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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There are several recommended doses of dexmedetomidine for prevention of emergence agitation in children. In this study, the investigators examine ED50 in prevention of emergence agitation after tonsillectomy or adenoidectomy in children.

Detailed Description

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To investigate ED50, Dixon's up and down method will be used.

Conditions

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Agitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexmedetomidine, children

Group Type OTHER

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine, 0.1ug/kg up or down

Interventions

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Dexmedetomidine

dexmedetomidine, 0.1ug/kg up or down

Intervention Type DRUG

Other Intervention Names

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precedex

Eligibility Criteria

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Inclusion Criteria

* tonsillectomy or adenoidectomy

Exclusion Criteria

* recent URI
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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SNUH

Principal Investigators

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Hee-Soo Kim, M.D, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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SNUH

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee-Soo Kim, M.D., PhD

Role: CONTACT

82220723659

Facility Contacts

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Hee-Soo Kim, M.D., PhD

Role: primary

82220723659

Other Identifiers

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KHS_1

Identifier Type: -

Identifier Source: org_study_id

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