Patients treated with therapeutic hypothermia (33-34 °C) and a control group of normothermic patients matched on sex, age and duration of morphine infusion.
Conditions
Interventions
Trade Name: MORFIN
Product Name: morphine
Pharmaceutical Form: Injection*
INN or Proposed INN: MORPHINE
CAS Number: 57272
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Co
Sponsors
The Norwegian University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients treated with therapeutic hypothermia (33-34°C) and a control group of critically ill patients at a normal temperature (36-38°C). • Controls will be matched on sex, age and duration of morphine infusion. • Patients must be 18 years or older. • Receiving continuous analgesia/sedation with morphine and midazolam for at least 12 hours. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant women • Cardiovascular unstable patients in deteriorating circulating status. • Renal failure calculated or measured renal clearance to less than 30. • Clinical significant liver failure. • Hemoglobin < 11 g/ • Known history of drug abuse (including cocaine, opiates, amphetamines, etc.) and alcoholism • History of drug allergies for the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the pharmacokinetics of morphine and midazolam during therapeutic hypothermia in order to review the current treatment. ;Secondary Objective: To retrieve information on the startup-pharmacokinetics of propofol and fentanyl;Primary end point(s): Terminal elimination half-life (t1/2ß) of morphine in hypothermic compared to normothermic patients in the ICU | — |
Countries
Norway
Outcome results
None listed