PainPAINCARENCT07564778
Pain After Cardiac Arrest and Resuscitation (PAINCARE)
An observational study of Pain and Out-of-hospital Cardiac Arrest (OHCA), run by Region Skane at 3 sites in Sweden.
Trial summary
The PAINCARE substudy is an observational cohort substudy nested within the international STEPCARE trial, which evaluates sedation, temperature, and mean arterial pressure strategies after out-of-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Out-of-hospital Cardiac Arrest (OHCA)
- How many people
- 300 participants
- Where
- 3 sitesSweden
- Study dates
- 15 Oct 2023to 31 Oct 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: STEPCARE participants at PAINCARE-participating sites who are included under approved PAINCARE substudy procedures and have not withdrawn consent for use of study data according to parent-trial procedures. PAINCARE participants may be included retrospectively or prospectively according to local approvals and substudy implementation.
Who may be able to join
- Out-of-hospital cardiac arrest
- Adult, age 18 years or older
- Spontaneous circulation without chest compressions for at least 20 minutes
- Comatose, defined as not obeying verbal commands
- Enrolled within 4 hours after return of spontaneous circulation
Who cannot join
- Restrictions or limitations of care
- On extracorporeal membrane oxygenation before randomization
- Pregnancy
- Previously randomized in the STEPCARE trial
- Trauma or hemorrhage as the presumed cause of arrest
- Suspected or confirmed intracranial hemorrhage
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Dep. of Intensive Care Halmstad Lasarett
Halmstad
Johan Undén, MD, PhD
- Recruiting
Department of Intensive Care, Skåne University Hospital
Malmö, 20205
Joachim P Düring, MD, PhD, +46705917599, joachim.during@med.lu.se
Mia H Hylén, RN, PhD, mia.hylen@skane.se
- Recruiting
Dep. of Intensive Care, Norrlands Universitets Sjukhus
Umeå
Matthias Schien
About this study
Official title: Characterizing and Quantifying Pain After Cardiac Arrest and Resuscitation: Insights From the PAINCARE Substudy of the STEPCARE Trial
The PAINCARE substudy is an observational cohort substudy nested within the international STEPCARE trial, which evaluates sedation, temperature, and mean arterial pressure strategies after out-of-hospital cardiac arrest. PAINCARE aims to describe the burden of pain during early intensive care after cardiac arrest and to evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Pain is common in critically ill patients but may be difficult to assess in patients who are unconscious, sedated, mechanically ventilated, or unable to self-report. PAINCARE collects structured pain assessments during the first 168 hours after randomization using validated self-report or behavioral pain instruments and relates early pain burden to outcomes including delirium burden, ventilator-free time, ICU-free time, and follow-up pain outcomes. All analyses are observational; PAINCARE is not designed to determine whether modifying pain burden improves outcomes.
Read the detailed description
PAINCARE is an exploratory observational substudy. The available sample size is expected to be approximately 300 participants and will be determined by PAINCARE participation, consent status, availability of PAINCARE data, and eligibility for the relevant analysis population. The primary analysis will estimate cumulative time in moderate/severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Secondary analyses will evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Missingness will be reported by variable, timepoint, site, and ascertainment mode where feasible. Prespecified analysis rules distinguish missing scorable intervals from non-scorable intervals, allow deterministic imputation only for isolated missing scorable intervals meeting prespecified criteria, and use endpoint-specific analysis populations for secondary and exploratory analyses. Sensitivity analyses will assess robustness to assumptions about pain-data completeness, deterministic imputation, non-scorable intervals, pain-state thresholds, and ascertainment mode. Analyses will be primarily descriptive and associational; findings outside the primary analysis will be considered hypothesis-generating. PAINCARE includes both retrospectively and prospectively ascertained participants according to local approvals and substudy implementation.
- Conditions
- Pain, Out-of-hospital Cardiac Arrest (OHCA)
- Keywords
- Chest compressions, delirium, quality of life, Cardiopulmonary resuscitation, Mechanical ventilation, ICU length of stay, critical care, cardiac arrest survivors, pain assessment
- Medical subject headings
- Pain, Out-of-Hospital Cardiac Arrest, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Comatose out-of-hospital cardiac arrest patients | Adult participants in the STEPCARE trial (NCT05564754) enrolled at PAINCARE-participating sites under approved PAINCARE substudy procedures and not withdrawn from use of study data according to parent-trial procedures. PAINCARE inclusion may occur retrospectively or prospectively according to local approvals and substudy implementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours
Cumulative time, in hours, spent in moderate or severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Moderate or severe pain is defined as NRS >3, CPOT >2, or BPS >5. Each scheduled assessment represents the worst pain intensity since the previous assessment and is assigned to the corresponding preceding interval.
Measured: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
Secondary outcomes (5)
Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours
Proportion of evaluable alive-in-ICU time spent in moderate or severe pain during the primary 0- to 168-hour pain-burden window. The proportion is calculated as cumulative evaluable time in moderate or severe pain divided by total evaluable alive-in-ICU time, excluding time after ICU discharge or death and excluding non-scorable and remaining missing scorable intervals.
Measured: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
Delirium Burden Through 168 Hours
Proportion of evaluable point-prevalence delirium assessments with delirium present among assessments recorded as delirium present or absent through 168 hours. Delirium is assessed using the Confusion Assessment Method for the ICU or the Intensive Care Delirium Screening Checklist. Assessments recorded as not assessable are reported separately and do not contribute to the denominator; assessments recorded as not done are reported as missing.
Measured: From randomization through 168 hours
Hours Alive and Free of Invasive Ventilatory Support Through Day 30
Number of hours from randomization to day 30 during which the participant is alive and not receiving invasive ventilatory support. Participants who die before day 30 are assigned zero hours alive and free of invasive ventilatory support.
Measured: From randomization through day 30
ICU-Free Days Alive Through Day 30
Number of days from randomization to day 30 during which the participant is alive and discharged from the ICU. Participants who die before day 30 are assigned zero ICU-free days.
Measured: From randomization through day 30
Moderate or Severe Pain at 1 Month
Moderate or severe pain at the 1-month follow-up assessment, defined as Numeric Rating Scale score greater than 3 for worst pain on movement during the preceding 24 hours.
Measured: At 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start15 Oct 2023
- Primary completion19 May 2026 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Düring, Region Skane
- Investigators
- Joachim P Düring, MD, PhD, Principal investigator, Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564778
- Sponsor's protocol ID
- STEPCARE_PAINCARE
- Acronym
- PAINCARE
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niemela VH, Reinikainen M, Nielsen N, Bass F, Young P, Lilja G, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Ceric A, Holgersson J, Kamp CB, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman E, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wise MP, McGuigan PJ, White J, Govier M, Maccaroni M, Ostermann M, Hopkins P, Proudfoot A, Handslip R, Pogson D, Jackson P, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Arnott C, Ramanan M, Panwar R, Delaney A, Reade M, Venkatesh B, Navarra L, Crichton B, Knight D, Williams A, Friberg H, Cronberg T, Jakobsen JC, Skrifvars MB. Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70040. doi: 10.1111/aas.70040.
PubMed 40392139Holgersson J, Niemela V, Skrifvars MB, Kamp-Jorgensen C, Saxena M, Young P, Bass F, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Ceric A, During J, Lybeck A, Rodriguez-Santos D, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Rosell J, Lotman EM, Navarra L, Crichton B, Knight D, Williams A, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wise M, Riddel J, Ahmed M, Buckel M, Mc Guigan P, Maharaj R, Wyncoll D, Thomas M, White J, Keeble TR, Pogson D, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Smid O, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Bernard S, Palmer-Simpson C, Simpson N, Ramanan M, Reade M, Delaney A, Venkatesh B, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen J, Nielsen N. Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70034. doi: 10.1111/aas.70034.
PubMed 40222389Ceric A, Dankiewicz J, Hastbacka J, Young P, Niemela VH, Bass F, Skrifvars MB, Hammond N, Saxena M, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Holgersson J, Kamp CB, Wise MP, McGuigan PJ, White J, Sweet K, Keeble TR, Glover G, Hopkins P, Remmington C, Cole JM, Gorgoraptis N, Pogson DG, Jackson P, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman EM, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi YM, Buabbas S, Yew Woon C, Aneman A, Stewart A, Reade M, Delcourt C, Delaney A, Ramanan M, Venkatesh B, Navarra L, Crichton B, Williams A, Knight D, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen JC, Nielsen N. Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70022. doi: 10.1111/aas.70022.
PubMed 40178107
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing and Quantifying Pain After Cardiac Arrest and Resuscitation: Insights From the PAINCARE Substudy of the STEPCARE Trial
- ClinicalTrials.gov ID
- NCT07564778
- Acronym / sponsor ID
- PAINCARE / STEPCARE_PAINCARE
- Conditions
- Pain, Out-of-hospital Cardiac Arrest (OHCA)
- Keywords
- Chest compressions, delirium, quality of life, Cardiopulmonary resuscitation, Mechanical ventilation, ICU length of stay, critical care, cardiac arrest survivors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 19 May 2026 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 4 May 2026 (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.
The PAINCARE substudy is an observational cohort substudy nested within the international STEPCARE trial, which evaluates sedation, temperature, and mean arterial pressure strategies after out-of-hospital cardiac arrest. PAINCARE aims to describe the burden of pain during early intensive care after cardiac arrest and to evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Pain is common in critically ill patients but may be difficult to assess in patients who are unconscious, sedated, mechanically ventilated, or unable to self-report. PAINCARE collects structured pain assessments during the first 168 hours after randomization using validated self-report or behavioral pain instruments and relates early pain burden to outcomes including delirium burden, ventilator-free time, ICU-free time, and follow-up pain outcomes. All analyses are observational; PAINCARE is not designed to determine whether modifying pain burden improves outcomes.
Detailed description
PAINCARE is an exploratory observational substudy. The available sample size is expected to be approximately 300 participants and will be determined by PAINCARE participation, consent status, availability of PAINCARE data, and eligibility for the relevant analysis population. The primary analysis will estimate cumulative time in moderate/severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Secondary analyses will evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Missingness will be reported by variable, timepoint, site, and ascertainment mode where feasible. Prespecified analysis rules distinguish missing scorable intervals from non-scorable intervals, allow deterministic imputation only for isolated missing scorable intervals meeting prespecified criteria, and use endpoint-specific analysis populations for secondary and exploratory analyses. Sensitivity analyses will assess robustness to assumptions about pain-data completeness, deterministic imputation, non-scorable intervals, pain-state thresholds, and ascertainment mode. Analyses will be primarily descriptive and associational; findings outside the primary analysis will be considered hypothesis-generating. PAINCARE includes both retrospectively and prospectively ascertained participants according to local approvals and substudy implementation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comatose out-of-hospital cardiac arrest patients | – | –Adult participants in the STEPCARE trial (NCT05564754) enrolled at PAINCARE-participating sites under approved PAINCARE substudy procedures and not withdrawn from use of study data according to parent-trial procedures. PAINCARE inclusion may occur retrospectively or prospectively according to local approvals and substudy implementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEPCARE participants at PAINCARE-participating sites who are included under approved PAINCARE substudy procedures and have not withdrawn consent for use of study data according to parent-trial procedures. PAINCARE participants may be included retrospectively or prospectively according to local approvals and substudy implementation.
Key inclusion criteria (5 listed)
- Out-of-hospital cardiac arrest
- Adult, age 18 years or older
- Spontaneous circulation without chest compressions for at least 20 minutes
- Comatose, defined as not obeying verbal commands
- Enrolled within 4 hours after return of spontaneous circulation
Key exclusion criteria (6 listed)
- Restrictions or limitations of care
- On extracorporeal membrane oxygenation before randomization
- Pregnancy
- Previously randomized in the STEPCARE trial
- Trauma or hemorrhage as the presumed cause of arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours
Time frame: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
Cumulative time, in hours, spent in moderate or severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Moderate or severe pain is defined as NRS >3, CPOT >2, or BPS >5. Each scheduled assessment represents the worst pain intensity since the previous assessment and is assigned to the corresponding preceding interval.
5 secondary outcomes
Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours
Time frame: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
Delirium Burden Through 168 Hours
Time frame: From randomization through 168 hours
Hours Alive and Free of Invasive Ventilatory Support Through Day 30
Time frame: From randomization through day 30
ICU-Free Days Alive Through Day 30
Time frame: From randomization through day 30
Moderate or Severe Pain at 1 Month
Time frame: At 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 40392139Niemela VH, Reinikainen M, Nielsen N, Bass F, Young P, Lilja G, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Ceric A, Holgersson J, Kamp CB, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman E, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wise MP, McGuigan PJ, White J, Govier M, Maccaroni M, Ostermann M, Hopkins P, Proudfoot A, Handslip R, Pogson D, Jackson P, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Arnott C, Ramanan M, Panwar R, Delaney A, Reade M, Venkatesh B, Navarra L, Crichton B, Knight D, Williams A, Friberg H, Cronberg T, Jakobsen JC, Skrifvars MB. Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70040. doi: 10.1111/aas.70040.
- Results publication: PubMed 40222389Holgersson J, Niemela V, Skrifvars MB, Kamp-Jorgensen C, Saxena M, Young P, Bass F, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Ceric A, During J, Lybeck A, Rodriguez-Santos D, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Rosell J, Lotman EM, Navarra L, Crichton B, Knight D, Williams A, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wise M, Riddel J, Ahmed M, Buckel M, Mc Guigan P, Maharaj R, Wyncoll D, Thomas M, White J, Keeble TR, Pogson D, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Smid O, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Bernard S, Palmer-Simpson C, Simpson N, Ramanan M, Reade M, Delaney A, Venkatesh B, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen J, Nielsen N. Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70034. doi: 10.1111/aas.70034.
- Results publication: PubMed 40178107Ceric A, Dankiewicz J, Hastbacka J, Young P, Niemela VH, Bass F, Skrifvars MB, Hammond N, Saxena M, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Holgersson J, Kamp CB, Wise MP, McGuigan PJ, White J, Sweet K, Keeble TR, Glover G, Hopkins P, Remmington C, Cole JM, Gorgoraptis N, Pogson DG, Jackson P, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman EM, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi YM, Buabbas S, Yew Woon C, Aneman A, Stewart A, Reade M, Delcourt C, Delaney A, Ramanan M, Venkatesh B, Navarra L, Crichton B, Williams A, Knight D, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen JC, Nielsen N. Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70022. doi: 10.1111/aas.70022.
- 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.
Joachim P Düring, MD, PhD principal investigator
Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Out-of-hospital Cardiac Arrest (OHCA), run by Region Skane at 3 sites in Sweden.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joachim P Düring, MD, PhD (+46705917599, joachim.during@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours (time frame: From randomization through 168 hours, ICU discharge, or death, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07564778, which also lists 3 linked publications.
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 14 May 2026.