Pain After Cardiac Arrest and Resuscitation (PAINCARE)

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours — 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.

Trial sites (3)

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