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NCT Number: NCT03432546

Acute and Persistent Pain in ICU Patients

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.

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Key information

Conditions

Critical Care Acute Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Central Hospital, Meilahti, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-interventional

Primary outcomes

  1. Incidence of acute pain

    Time frame: Through study completion, an average of 3 days

    Moderate or severe pain (numerical rating scale (NRS) value above 3 / critical pain observatory tool (CPOT) value ≥3) during intensive care

  2. Incidence of persistent neuropathic pain using Pain Detect

    Time frame: At intensive care follow up clinic at three months after discharge and thereafter the change in pain annually for 5 years

    Moderate or severe pain.

  3. Incidence of anxiety affecting persistent pain

    Time frame: At intensive care follow up clinic at three months after discharge and thereafter the change in anxiety annually for 5 years

    State Trait anxiety Index T (STAI-T)

Secondary outcomes

  1. Analgesic use

    Time frame: Through study completion, an average of 3 days

    Analgesics administered during intensive care including indications and dosages

  2. Delirium

    Time frame: Through study completion, an average of 3 days

    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

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Helsinki University Central Hospital
  • Töölö Hospital

Registry information

Official study title

Acute and Persistent Pain in Intensive Care Patients

Acronym: PAIN-ICU

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2018
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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