Acute and Persistent Pain in ICU Patients

Chronic Pain Clinical Trial

— PAIN-ICU  

Official title:

Acute and Persistent Pain in Intensive Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432546
• Other study ID #: HUS/2779/2017
• Status: Completed
• Start date: April 6, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Critical Care

Intervention

Other:
• Non-interventional
Non-interventional

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Meilahti	Helsinki
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Helsinki University Central Hospital, Töölö Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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