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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
- ClinicalTrials.gov ID
- NCT01091818
- Acronym / sponsor ID
- dexmedetmidazchildintsed
- Conditions
- Sedation
- Keywords
- To see if sedation with dexmedetomidine results in faster emergence after end of intensive care treatment in children, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam | Active comparator | Drug: Midazolam |
| dexmedetomidin | Experimental | Drug: dexmedetomidine |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineAlso: Midazolam is given as major sedative drugDexemedethomidine is given as major sedative drug | Drug | dexmedetomidin |
| MidazolamMidazolam is given as major sedative drug | Drug | midazolam |
Primary outcome
Time from end of sedation to extubation
Time frame: 1-24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
Related trials for Sedation
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexmedetomidine and Midazolam in people with Sedation, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from end of sedation to extubation (time frame: 1-24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.