Acute and Persistent Pain in ICU Patients (PAIN-ICU)

Acute and Persistent Pain in Intensive Care 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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Acute Pain; Critical Care
• Intervention / Treatment: Other: Non-interventional

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.

• Study Type: Observational
• Enrollment (Actual): 707

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Central Hospital, Meilahti
  • Tampere, Finland
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort of intensive care patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU patients; Over 18-year old intensive care patients, non-interventional prospective observational study	Other: Non-interventional; Non-interventional

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Helsinki University Central Hospital; Töölö Hospital
• Investigators: Study Chair: Maija-Liisa Kalliomäki, Tampere University Hospital; Study Chair: Otto Mäkinen, Tampere University; Study Chair: Sari Karlsson, Tampere University Hospital; Study Chair: Simo Varila, Tampere University Hospital; Study Chair: Minna Peltomaa, Tampere University Hospital; Study Chair: Karita Koskinen, HUS; Study Chair: Anna-Maria Kuivalainen, HUS; Study Chair: Katri Hamunen, HUS Pain Clinic; Study Chair: Minna Bäcklund, HUS; Study Chair: Sari Sutinen, HUS; Study Chair: Leena Pettilä, HUS; Study Chair: Annika Laukkanen, Töölö Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2018
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (ACTUAL): February 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain
• Other Study ID Numbers: HUS/2779/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No