all patients admitted to the ICU of the St. Antonius hospital (>18 years old)
Conditions
Interventions
Trade Name: Morphine HCL CF 10 mg/ ml, for intravenous use
Product Name: Morphine
Pharmaceutical Form: Injection*
Trade Name: Morphine HCL CF 10 mg/ ml, for intravenous use
Product Name: Morphine
P
Sponsors
St. Antonius Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients admitted to the ICU of the St. Antonius hospital, with the age of 18 years or older 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: - Pregnancy/ breastfeeding - Language barrier - Known morphine allergy - Comatose patient (cooled) - Patients who are suspected to be braindead - Unintubated patients on the verge of intubation due to respiratory insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the influence of morphine dosage (2.5 mg vs 7.5 mg) on the percentage of patients with a rated NRS of = 4 during an painful and unavoidable intervention. ;Secondary Objective: The secondary objectives are to evaluate NRS scores, safety and other aspects of both the intervention related pain protocol (morphine 2.5 mg vs 7.5 mg) as well as the standard pain titration protocol aiming at pain control in rest (paracetamol and morphine). Additionally, a population pharmacokinetic and pharmacodynamic model of morphine and its metabolites will be developed using population pharmacokinetics and/or pharmacodynamics (PK/PD) modelling and covariate analysis in order to develop rational individualized dosing schemes for morphine in ICU patients. Whenever possible the level of sedation or concentration of sedative will be incorporated in the model leading to an analgo-sedative model. ;Primary end point(s): The primary endpoint is to determine the percentage of patients with a NRS of = 4 during intervention (2.5 mg versus 7.5 mg morphine) | — |
Countries
Netherlands
Outcome results
None listed