Acute and Persistent Pain in ICU Patients

NCT03432546 | Completed

• 1 other identifier: HUS/2779/2017
• Study Type: observational
• Target: 707
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Care; Acute Pain; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Analgesic use

  Through study completion, an average of 3 days

• Delirium

  Through study completion, an average of 3 days

Study Arms (1)

ICU patients

Over 18-year old intensive care patients, non-interventional prospective observational study

Other: Non-interventional

Interventions

Non-interventional OTHER

Non-interventional

ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort of intensive care patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Töölö Hospital: collaborator

Study Sites (2)

Helsinki University Central Hospital, Meilahti

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: February 14, 2018
• Study Start: April 6, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)