NCT01091818

Brief Summary

Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years. The investigators' primary hypothesis is that time from end of medication to extubation will be shorter with dexmedetomidine sedation.

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
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

Enrollment Period

1.6 years

First QC Date

March 22, 2010

Last Update Submit

July 20, 2011

Conditions

Sedation

Keywords

To see if sedation with dexmedetomidine results in faster emergence after end of intensive care treatment in childrentreatment

Outcome Measures

Primary Outcomes (1)

  • Time from end of sedation to extubation

    1-24 hrs

Study Arms (2)

midazolam

ACTIVE COMPARATOR
Drug: Midazolam

dexmedetomidin

EXPERIMENTAL
Drug: dexmedetomidine

Interventions

dexmedetomidineDRUG

Dexemedethomidine is given as major sedative drug

Also known as: Midazolam is given as major sedative drug
dexmedetomidin
MidazolamDRUG

Midazolam is given as major sedative drug

midazolam

Eligibility Criteria

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

You may qualify if:

  • informed consent from parents
  • age between 2 and 18 years
  • anticipated need of respirator treatment for more than 24 hrs
  • included in study within 48 hrs of admission to intensive care unit (ICU)

You may not qualify if:

  • severe, unstable circulatory failure
  • severe intracranial or spinal trauma with circulatory instability
  • sever bradycardia or atrioventricular (A-V) block
  • liver failure
  • less than 50% chance of anticipated survival
  • known allergy to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, 0407, Norway

RECRUITING

MeSH Terms

Interventions

DexmedetomidineMidazolam

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 24, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

July 21, 2011

Record last verified: 2011-07

Locations

NO(1)