Dexmedetomidine Versus Midazolam for Intensive Care Sedat... | NCT01091818

Studies
Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

NCT01091818

Sponsor

Ullevaal University Hospital

Status

Unknown status

Last Update Posted

Jul 21, 2011Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Sedation

Interventions

dexmedetomidine
Midazolam

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Oct 2011Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Mar 22, 2010

First Submission Date that Met QC Criteria

Mar 23, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2011

Last Update Posted Date

Jul 21, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
midazolam	Active Comparator		Drug: Midazolam
dexmedetomidin	Experimental		Drug: dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dexmedetomidine	Drug	Dexemedethomidine is given as major sedative drug	dexmedetomidin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time from end of sedation to extubation		1-24 hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Anesthesiology, Oslo University Hospital, Ullevaal	Recruiting	Oslo		0407	Norway

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D008874	Midazolam

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided