RecruitingNCT07564778

PAIN AFTER CARDIAC ARREST AND RESUSCITATION

Characterizing and Quantifying Pain After Cardiac Arrest and Resuscitation: Insights From the PAIN CARE Substudy of the STEPCARE Trial


Sponsor

Region Skane

Enrollment

400 participants

Start Date

Oct 15, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The PAINCARE study is a substudy of the international STEPCARE trial, which investigates sedation, analgesia, and outcomes after cardiac arrest. The purpose of PAINCARE is to examine how pain, its assessment, and its treatment are related to delirium, resource use, and long-term outcomes in patients who have been resuscitated after cardiac arrest and treated in the intensive care unit (ICU). Pain is frequent in critically ill patients but often underrecognized and undertreated, particularly among those who are sedated or mechanically ventilated. After cardiac arrest, patients may experience pain caused by chest compressions, invasive procedures, or prolonged immobilization. Despite this, little is known about how pain is assessed and managed in this group or how pain and analgesic treatment influence clinical recovery and patient-reported outcomes. PAINCARE will collect detailed information on pain intensity, pain assessments, and analgesic use in parallel with data on sedation, delirium, and recovery. Data will be obtained through the same electronic case report form (eCRF) and procedures as the main STEPCARE trial. The main question PAINCARE aims to answer is: How are pain and pain management related to delirium, ICU resource use, and long-term outcomes in patients who have survived cardiac arrest? By improving understanding of pain and its management in this vulnerable patient group, the study seeks to inform better pain assessment and treatment strategies in the ICU, with the ultimate goal of improving comfort, reducing complications such as delirium, and supporting better recovery for survivors of cardiac arrest.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Out-of-hospital Cardiac Arrest
  • Adult(≥18years)
  • Spontaneous circulation without chest compressions ≥20 min
  • Comatose(Does not obey commands)
  • Enrolled within 4h after ROSC

Exclusion Criteria6

  • Restrictions or limitations of care
  • On ECMO prior to randomization
  • Pregnancy
  • Previously randomized in the STEPCARE trial
  • Trauma or hemhorrage as presumed cause of arrest
  • Suspected or confirmed intracranial hemhorrage

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Locations(3)

Dep. of Intensive Care Halmstad Lasarett

Halmstad, Sweden

Department of Intensive Care, Skåne University Hospital

Malmö, Sweden

Dep. of Intensive Care, Norrlands Universitets Sjukhus

Umeå, Sweden

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NCT07564778


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