Clinical trial NCT03432546: Acute and Persistent Pain in ICU Patients
Official title: Acute and Persistent Pain in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Acute Pain
Chronic Pain
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Töölö Hospital
First posted: 2018-02-14
Enrollment: 707
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective cohort of intensive care patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of acute pain
timeFrame: Through study completion, an average of 3 days
measure: Incidence of persistent neuropathic pain using Pain Detect
timeFrame: At intensive care follow up clinic at three months after discharge and thereafter the change in pain annually for 5 years
measure: Incidence of anxiety affecting persistent pain
timeFrame: At intensive care follow up clinic at three months after discharge and thereafter the change in anxiety annually for 5 years
Secondary outcomes:
measure: Analgesic use
timeFrame: Through study completion, an average of 3 days
measure: Delirium
timeFrame: Through study completion, an average of 3 days
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Meilahti
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Maija-Liisa Kalliomäki
role: STUDY_CHAIR
affiliation: Tampere University
name: Otto Mäkinen
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Sari Karlsson
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Simo Varila
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Minna Peltomaa
role: STUDY_CHAIR
affiliation: HUS
name: Karita Koskinen
role: STUDY_CHAIR
affiliation: HUS
name: Anna-Maria Kuivalainen
role: STUDY_CHAIR
affiliation: HUS Pain Clinic
name: Katri Hamunen
role: STUDY_CHAIR
affiliation: HUS
name: Minna Bäcklund
role: STUDY_CHAIR
affiliation: HUS
name: Sari Sutinen
role: STUDY_CHAIR
affiliation: HUS
name: Leena Pettilä
role: STUDY_CHAIR
affiliation: Töölö Hospital
name: Annika Laukkanen
role: STUDY_CHAIR
References: