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NCT Number: NCT07564778

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.

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Key information

Conditions

Pain Cardiovascular Diseases Confusion Delirium Heart Arrest Heart Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Out-Of-Hospital Cardiac Arrest (OHCA) Out-of-Hospital Cardiac Arrest Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Intensive Care Halmstad Lasarett, Halmstad, Sweden

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About this study

PAINCARE is an exploratory observational substudy. The available sample size is expected to be approximately 300 participants and will be determined by PAINCARE participation, consent status, availability of PAINCARE data, and eligibility for the relevant analysis population. The primary analysis will estimate cumulative time in moderate/severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Secondary analyses will evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Missingness will be reported by variable, timepoint, site, and ascertainment mode where feasible. Prespecified analysis rules distinguish missing scorable intervals from non-scorable intervals, allow deterministic imputation only for isolated missing scorable intervals meeting prespecified criteria, and use endpoint-specific analysis populations for secondary and exploratory analyses. Sensitivity analyses will assess robustness to assumptions about pain-data completeness, deterministic imputation, non-scorable intervals, pain-state thresholds, and ascertainment mode. Analyses will be primarily descriptive and associational; findings outside the primary analysis will be considered hypothesis-generating. PAINCARE includes both retrospectively and prospectively ascertained participants according to local approvals and substudy implementation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours

    Time frame: From randomization through 168 hours, ICU discharge, or death, whichever occurs first

    Proportion of evaluable alive-in-ICU time spent in moderate or severe pain during the primary 0- to 168-hour pain-burden window. The proportion is calculated as cumulative evaluable time in moderate or severe pain divided by total evaluable alive-in-ICU time, excluding time after ICU discharge or death and excluding non-scorable and remaining missing scorable intervals.

  2. Delirium Burden Through 168 Hours

    Time frame: From randomization through 168 hours

    Proportion of evaluable point-prevalence delirium assessments with delirium present among assessments recorded as delirium present or absent through 168 hours. Delirium is assessed using the Confusion Assessment Method for the ICU or the Intensive Care Delirium Screening Checklist. Assessments recorded as not assessable are reported separately and do not contribute to the denominator; assessments recorded as not done are reported as missing.

  3. Hours Alive and Free of Invasive Ventilatory Support Through Day 30

    Time frame: From randomization through day 30

    Number of hours from randomization to day 30 during which the participant is alive and not receiving invasive ventilatory support. Participants who die before day 30 are assigned zero hours alive and free of invasive ventilatory support.

  4. ICU-Free Days Alive Through Day 30

    Time frame: From randomization through day 30

    Number of days from randomization to day 30 during which the participant is alive and discharged from the ICU. Participants who die before day 30 are assigned zero ICU-free days.

  5. Moderate or Severe Pain at 1 Month

    Time frame: At 1 month

    Moderate or severe pain at the 1-month follow-up assessment, defined as Numeric Rating Scale score greater than 3 for worst pain on movement during the preceding 24 hours.

Other outcomes

  1. Moderate or Severe Pain at 6 Months

    Time frame: At 6 months

    Moderate or severe pain at the 6-month follow-up assessment, defined as Numeric Rating Scale score greater than 3 for worst pain on movement during the preceding 24 hours.

  2. Health-Related Quality of Life at 6 Months

    Time frame: At 6 months

    Health-related quality of life at 6 months assessed using EQ-5D-5L. For exploratory binary analyses, clinically relevant health-related quality-of-life problems are defined as at least one EQ-5D-5L dimension scored at level 3 or higher. EQ-5D-5L dimension profiles and EQ VAS will also be summarized descriptively.

  3. Mobilization During ICU Care

    Time frame: From randomization through 168 hours

    Mobilization during ICU care categorized as ICU Mobility Scale greater than 1 versus 1 or lower.

Study contacts

Contact information is provided by the study sponsor or research team.

Joachim P Düring, MD, PhD

CONTACT

[email protected]

+46705917599

Mia H Hylén, RN, PhD

CONTACT

[email protected]

+46708277226

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Acronym: PAINCARE

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
May 4, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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