Acute and Persistent Pain in ICU Patients

NCT ID: NCT03432546

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

707 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-06

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Critical Care Acute Pain Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU patients

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

Non-interventional

Intervention Type OTHER

Non-interventional

Interventions

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Non-interventional

Non-interventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Töölö Hospital

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maija-Liisa Kalliomäki

Role: STUDY_CHAIR

Tampere University Hospital

Otto Mäkinen

Role: STUDY_CHAIR

Tampere University

Sari Karlsson

Role: STUDY_CHAIR

Tampere University Hospital

Simo Varila

Role: STUDY_CHAIR

Tampere University Hospital

Minna Peltomaa

Role: STUDY_CHAIR

Tampere University Hospital

Karita Koskinen

Role: STUDY_CHAIR

HUS

Anna-Maria Kuivalainen

Role: STUDY_CHAIR

HUS

Katri Hamunen

Role: STUDY_CHAIR

HUS Pain Clinic

Minna Bäcklund

Role: STUDY_CHAIR

HUS

Sari Sutinen

Role: STUDY_CHAIR

HUS

Leena Pettilä

Role: STUDY_CHAIR

HUS

Annika Laukkanen

Role: STUDY_CHAIR

Töölö Hospital

Locations

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Helsinki University Central Hospital, Meilahti

Helsinki, , Finland

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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HUS/2779/2017

Identifier Type: -

Identifier Source: org_study_id

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