Pain After Cardiac Arrest and Resuscitation (PAINCARE)

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.

NCT Number	NCT07564778
Lead Sponsor	Region Skane
Conditions	Pain, Out-of-hospital Cardiac Arrest (OHCA)
Enrollment	300 participants
Start Date	2023-10-15
Primary Completion	2026-05-19 (estimated)
Study Completion	2028-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-14