Paediatric patients requiring mecanical ventilation and sedation in PICU.
Conditions
Interventions
Trade Name: Precedex 100micrograms/ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: dexmedetomidine (precedex)
CAS Number: 145108-58-3
Concentration unit: µg/ml micro
Sponsors
Dept. of Anaesthesia, Oslo University Hospital, Ullevål
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to elucidate whether sedation with dexmedetomidine will result in shorter time from decision of awakening until extubation than the traditional sedation with midazolam.;Secondary Objective: Will dexmedetomidine result in better quality in the first post extubation phase? Will dexmedetomidine result inn less overall need of opioids during sedation, and less opioid induced side-effects?;Primary end point(s): 1) Time from stop of sedative medication until extubation. 2) Incidence of pain and amount of rescue pain medication during sedation and after end of sedation. 3) Incidence of hypoxia, hypercarbia, re-intubation, nausea, restlessness, sleep disturbances after extubation. 4) Incidence of opioid inducd side-effects. | — |
Countries
Norway
Outcome results
None listed