Acute and Persistent Pain in ICU Patients

Acute and Persistent Pain in Intensive Care Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03432546

Acronym

PAIN-ICU

Enrollment

707

Registered

2018-02-14

Start date

2018-04-06

Completion date

2021-12-31

Last updated

2022-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Chronic Pain, Critical Care

Brief summary

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

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.

Interventions

OTHERNon-interventional

Non-interventional

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* not meeting the

Design outcomes

Primary

Measure	Time frame	Description
Incidence of acute pain	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
Incidence of persistent neuropathic pain using Pain Detect	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.
Incidence of anxiety affecting persistent pain	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

Measure	Time frame	Description
Analgesic use	Through study completion, an average of 3 days	Analgesics administered during intensive care including indications and dosages
Delirium	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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026