Critical Illness
Conditions
Keywords
pain, Intensive Care Unit, morphine, pKpD, numerical rating scale, critically ill patients
Brief summary
The purpose of this study is to determine the influence of morphine 2,5 mg or morphine 7,5 mg iv during a painful and unavoidable intervention in critically ill patients.
Detailed description
In 2006, in the Intensive Care Unit (ICU) of the St. Antonius Hospital an analgesia improvement program has been implemented. This program consisted of training of ICU nurses and intensivists using a hospital based standardized pain protocol, and systematic pain measurements in rest, rated by the patient himself whenever possible or otherwise by the attending nurse. This program has resulted in a reduction of severe pain levels (NRS≥4) in ICU patients in rest from 41% to 22%. In order to further reduce this percentage, a pain titration protocol is introduced in 2007. As no attention has yet been paid to intervention-related pain levels in these patients, in this prospective study pain control will be studied using different analgesic dosages of morphine iv (2,5 mg vs 7,5 mg) around unavoidable painful interventions within a pain titration protocol for pain control in rest.
Interventions
DRUGmorphine
patients receive 7,5 mg morphine iv 30 minutes before intervention (turning of the patient), the day after admission in the ICU. before, during and after, the patient will be asked to rate the pain using the NRS
Sponsors
Erasmus Medical Center
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted to the ICU of the St. Antonius hospital, between 18-85 years old en weighing between 45-140 kg.
Exclusion criteria
* Pregnancy/ breastfeeding * Language barrier * Known morphine iv allergy * Comatose patients (cooled) * Patients who are suspected to be brain-dead * Unintubated patients on the verge of intubation due to respiratory insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with a NRS of ≥ 4 during intervention (2.5 mg versus 7.5 mg morphine iv) | The first intervention one day after admission |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay | 10 days |
| The mean NRS per patient in rest during ICU stay | 10 days |
| The percentage of patients with a NRS of ≥ 6 during intervention (2.5 mg versus 7.5 mg morphine iv) | one day after admission in the ICU |
| The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv) | 10 days |
| Pharmacodynamic parameters of morphine iv (EC50 etc) | 10 days |
| Covariates for the PK/PD of morphine iv | 10 days |
| Safety and other measures of the analgesics (morphine iv and paracetamol) used for intervention related pain as well as pain titration protocol for pain control in rest. | 10 days |
| Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values) | 10 days |
Countries
Netherlands
Outcome results
None listed