The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>patients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU | Drug: morphine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, Intensive Care Unit, morphine, pKpD, numerical rating scale, critically ill patients