NCT01374737

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

June 9, 2011

Last Update Submit

June 15, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • agitation

    30 minutes

Secondary Outcomes (1)

  • pain

    30 minutes

Study Arms (1)

dexmedetomidine, children

OTHER
Drug: Dexmedetomidine

Interventions

dexmedetomidine, 0.1ug/kg up or down

Also known as: precedex
dexmedetomidine, children

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • tonsillectomy or adenoidectomy

You may not qualify if:

  • recent URI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, 110744, South Korea

RECRUITING

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hee-Soo Kim, M.D, PhD

    Seoul National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Hee-Soo Kim, M.D., PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 16, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations