SedationPhase 3NCT01091818
Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
A Phase 3 study testing dexmedetomidine and Midazolam in people with Sedation, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Sedation
- What is being tested?
- dexmedetomidine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Oct 2011
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, 0407
Johan Rader, PhD, 004792249669, johan.rader@medisin.uio.no
About this study
Official title: A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
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.
- Conditions
- Sedation
- Being tested
- dexmedetomidine, Midazolam
- Keywords
- To see if sedation with dexmedetomidine results in faster emergence after end of intensive care treatment in children, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called Midazolam is given as major sedative drug
Dexemedethomidine is given as major sedative drug
MidazolamDrug
Midazolam is given as major sedative drug
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Active comparator | Not described Receives: Drug: Midazolam |
| dexmedetomidin | Experimental | Not described Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from end of sedation to extubation
Measured: 1-24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091818
- Sponsor's protocol ID
- dexmedetmidazchildintsed
- Status last verified
- Jul 2011
- First submitted
- 22 Mar 2010
- Last updated
- 21 Jul 2011
- Results posted
- No