Dexmedetomidine versus midazolam til sedasjon av pediatriske intensivpasienter ved Oslo Universitetssykehus. - DEX-studie

Phase 1

Conditions: Paediatric patients requiring mecanical ventilation and sedation in PICU.

Registration Number: EUCTR2009-011112-37-NO

Lead Sponsor: Dept. of Anaesthesia, Oslo University Hospital, Ullevål

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

-Written, informed consent from the parents.
-Age 2-18 years.
-Expected need of sedation > 24 hours from time of randomization
-Randomization should be < 72 hours from ICU admission and < 48 hours of commencing continous sedation in the ICU
-Acute severe intracranial or spinal neurologic disorders, only when ciculatory stable and for acute intracerebral disorders only when monitoring ICP, and with adequate CPP.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Acute severe intracranial or spinal neurologic disorder when circulatory unstable, and with not adequate CPP.
-Uncompensated circulatory failure at time of randomization
-Severe bradycardia
-AV conduction block II-III (unless pacemaker installed)
-Severe hepatic impairment (bilirubin > 100umol/l)
-Need for muscle relaxation at the time of randomization (may only be used for intubation and initial stabilization)
-Use of centrally acting alpha 2 agonist or antagonists at the time of randomization, notably clonidine.
-Patients with poor survival prognosis, and patients who are unlikely to be weaned from mecanical ventilation.
-Patients receiving sedation for theapeutic indications rather than to tolerate the ventilator (e.g. epilepsy)
-Positive pregnancy test or currently lactating
-Any other condition which, in the investigator`s opinion would make it detrimental for the subject to participate in the study.