Critical CarePAIN-ICUNCT03432546
Acute and Persistent Pain in ICU Patients
An observational study of Critical Care and Acute Pain, run by Tampere University Hospital at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Acute Pain, Chronic Pain
- What is being tested?
- Non-interventional
- How many people
- 707 participants
- Where
- 2 sitesFinland
- Study dates
- 6 Apr 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective cohort of intensive care patients
Who may be able to join
- not meeting the exclusion criteria
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital, Meilahti
Helsinki
Tampere University Hospital
Tampere
About this study
Official title: Acute and Persistent Pain in Intensive Care Patients
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.
Read the 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.
- Conditions
- Critical Care, Acute Pain, Chronic Pain
- Being tested
- Non-interventional
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Over 18-year old intensive care patients, non-interventional prospective observational study Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 3 days
Incidence of persistent neuropathic pain using Pain Detect
Moderate or severe pain.
Measured: At intensive care follow up clinic at three months after discharge and thereafter the change in pain annually for 5 years
Incidence of anxiety affecting persistent pain
State Trait anxiety Index T (STAI-T)
Measured: At intensive care follow up clinic at three months after discharge and thereafter the change in anxiety annually for 5 years
Secondary outcomes (2)
Analgesic use
Analgesics administered during intensive care including indications and dosages
Measured: Through study completion, an average of 3 days
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
Measured: Through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start6 Apr 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Töölö Hospital
- Responsible party
- Sponsor
- Investigators
- Maija-Liisa Kalliomäki, Study chair, Tampere University HospitalOtto Mäkinen, Study chair, Tampere UniversitySari Karlsson, Study chair, Tampere University HospitalSimo Varila, Study chair, Tampere University HospitalMinna Peltomaa, Study chair, Tampere University HospitalKarita Koskinen, Study chair, HUSAnna-Maria Kuivalainen, Study chair, HUSKatri Hamunen, Study chair, HUS Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432546
- Sponsor's protocol ID
- HUS/2779/2017
- Acronym
- PAIN-ICU
- Status last verified
- Oct 2022
- First submitted
- 20 Dec 2017
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Persistent Pain in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT03432546
- Acronym / sponsor ID
- PAIN-ICU / HUS/2779/2017
- Conditions
- Critical Care, Acute Pain, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Töölö Hospital
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Non-interventionalOver 18-year old intensive care patients, non-interventional prospective observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort of intensive care patients
Key inclusion criteria (1 listed)
- not meeting the exclusion criteria
Key exclusion criteria (7 listed)
- pregnant patients
- age under 18 years
- suffering from significant brain injury
- elective neurosurgical patients
- probable organ donors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalNon-interventional | Other | ICU patients |
Primary outcome
Incidence of acute pain
Time frame: 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
Incidence of persistent neuropathic pain using Pain Detect
Time frame: 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
Time frame: 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)
2 secondary outcomes
Analgesic use
Time frame: Through study completion, an average of 3 days
Delirium
Time frame: Through study completion, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maija-Liisa Kalliomäki study chair
Tampere University Hospital
Otto Mäkinen study chair
Tampere University
Sari Karlsson study chair
Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care and Acute Pain, run by Tampere University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute pain (time frame: Through study completion, an average of 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.