About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Restrictions or limitations of care
On extracorporeal membrane oxygenation before randomization
Pregnancy
Previously randomized in the STEPCARE trial
Trial design
Treatments tested in this trial
- Not listed