Pain After Cardiac Arrest and Resuscitation (PAINCARE) (NCT07564778) | Clinical Trial Compass
RecruitingNot Applicable
Pain After Cardiac Arrest and Resuscitation (PAINCARE)
Sweden300 participantsStarted 2023-10-15
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically measuring pain in patients after an out-of-hospital cardiac arrest who are in the ICU — does my loved one's situation match what this study is looking for, and would they even be able to participate given how critical the first hours after cardiac arrest can be?
2The study tracks moderate or severe pain over a 168-hour window in the ICU — what does that kind of pain monitoring actually look like day-to-day, and how might it affect the care my loved one is already receiving?
3Since this trial is listed as 'Phase NA,' it seems more focused on observing and measuring pain rather than testing a new drug or device — can you explain what that means for any risks to my loved one compared to standard post-cardiac arrest care?
4Cardiac arrest survivors often can't speak for themselves in the ICU — who would be making decisions about participation on their behalf, and what rights do we as family members have to withdraw them from the study if we're uncomfortable?
5Are there standard pain management protocols already used after cardiac arrest that this trial might complement or potentially delay, and would enrolling affect any other treatment decisions being made during that critical 168-hour period?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours
Timeframe: From randomization through 168 hours, ICU discharge, or death, whichever occurs first