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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03432546
Other study ID # HUS/2779/2017
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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