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| ID | Type | Description | Link |
|---|---|---|---|
| NL18828.100.07 |
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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | patients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| morphine | Drug | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv) | 10 days | |
| The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay | 10 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherijne AJ Knibbe, Pharm D | St Antonius Hospital, Department of Clinical Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St antonius Hospital | Nieuwegein | 3430 EM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33122543 | Derived | Goulooze SC, Krekels EH, Saleh MA, Ahlers SJ, Valitalo PA, van Dongen EP, van Schaik RH, Hankemeier T, Tibboel D, Knibbe CAJ. Predicting Unacceptable Pain in Cardiac Surgery Patients Receiving Morphine Maintenance and Rescue Doses: A Model-Based Pharmacokinetic-Pharmacodynamic Analysis. Anesth Analg. 2021 Mar 1;132(3):726-734. doi: 10.1213/ANE.0000000000005228. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| 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 |
| Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values) | 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 |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |