Acute and Persistent Pain in ICU Patients

Study Overview
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Brief Summary
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Approximately 20,000 patients are treated in intensive care units (ICU) in Finland annually. During ICU stay many diagnostic and other procedures as well as immobilization and underlying diseases may cause pain. Therefore the incidence of pain in ICU patients can be high. Acute pain may cause several detrimental effects including respiratory distress, tissue hypoxia, immunosuppression and anxiety. After discharge many survivors of critical care have lower health-related quality of life, symptoms of post-traumatic stress disorder or persistent pain. Only few studies with a focus on acute or persistent pain in ICU patients have been made, hence the incidence and risk factors for ICU-related pain is not very well known. Some of the identified risk factors for persisting pain may be increased age, sepsis or inadequate pain management during ICU stay. Opioids are most often used for analgesics in intensive care. Because they may have several adverse effects the use must be based on validated pain scales. Many factors such as sedation, relaxation or delirium of the patient complicates the management of the pain. This prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in ICU patients as well as and the use of analgesics during intensive care.

Detailed Description
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This prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in ICU patients as well as and the use of analgesics during intensive care. The recruitement process is finished, but the follow-up is on-going. Patients are followed-up by subsequent questionnaires until 5 years after admission to the ICU.

Official Title
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Acute and Persistent Pain in Intensive Care Patients

Conditions
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Critical Care, Acute Pain, Chronic Pain

Intervention / Treatment
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* Other: Non-interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: not meeting the exclusion criteria Exclusion Criteria: pregnant patients age under 18 years suffering from significant brain injury elective neurosurgical patients probable organ donors suffering from significant cognitive impairment presumed death under 48h

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU patients<br>Over 18-year old intensive care patients, non-interventional prospective observational study | Other: Non-interventional<br>* Non-interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute pain | Moderate or severe pain (numerical rating scale (NRS) value above 3 / critical pain observatory tool (CPOT) value ≥3) during intensive care | Through study completion, an average of 3 days | 
| Incidence of persistent neuropathic pain using Pain Detect | Moderate or severe pain. | At intensive care follow up clinic at three months after discharge and thereafter the change in pain annually for 5 years | 
| Incidence of anxiety affecting persistent pain | State Trait anxiety Index T (STAI-T) | At intensive care follow up clinic at three months after discharge and thereafter the change in anxiety annually for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic use | Analgesics administered during intensive care including indications and dosages | Through study completion, an average of 3 days | 
| Delirium | Incidence of delirium during intensive care by using Intensive Care Delirium Screening Checklist (ICDSC, scores 0-8) scale, a sum of symptoms equal or above 4 is considered affirmative for delirium | Through study completion, an average of 3 days |