Acute and Persistent Pain in ICU Patients

Completed

• Conditions: Chronic Pain; Critical Care; Acute Pain
• Interventions: Other: Non-interventional

• Registration Number: NCT03432546
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-14
• Study Start: 2018-04-06
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 707

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU patients	Non-interventional	Over 18-year old intensive care patients, non-interventional prospective observational study

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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
Analgesic use	Through study completion, an average of 3 days	Analgesics administered during intensive care including indications and dosages

Trial Locations

Locations (2)

Helsinki University Central Hospital, Meilahti; 🇫🇮 Helsinki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland