Pain After Cardiac Arrest and Resuscitation (PAINCARE)
Recruiting now
Conditions studied: Pain, Out-of-hospital Cardiac Arrest (OHCA)
In brief
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.
Key facts
- Study ID
- NCT07564778
- Run by
- Region Skane
- People needed
- 300
- Starts
- 2023-10-15
- Expected to finish
- 2028-10-31
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dep. of Intensive Care Halmstad Lasarett — Halmstad, Sweden (enrolling)
- Department of Intensive Care, Skåne University Hospital — Malmö, Sweden (enrolling)
- Dep. of Intensive Care, Norrlands Universitets Sjukhus — Umeå, Sweden (enrolling)
Full record on ClinicalTrials.gov
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