An observational study in Pain and Out-of-hospital Cardiac Arrest (OHCA), sponsored by Region Skane. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Region Skane · Observational
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 1,252 observational studies indexed under Pain.
Browse Pain studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
STEPCARE participants at PAINCARE-participating sites who are included under approved PAINCARE substudy procedures and have not withdrawn consent for use of study data according to parent-trial procedures. PAINCARE participants may be included retrospectively or prospectively according to local approvals and substudy implementation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult participants in the STEPCARE trial (NCT05564754) enrolled at PAINCARE-participating sites under approved PAINCARE substudy procedures and not withdrawn from use of study data according to parent-trial procedures. PAINCARE inclusion may occur retrospectively or prospectively according to local approvals and substudy implementation.
Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours
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.
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 Through 168 Hours
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.
Time frame: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
Delirium Burden 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.
Time frame: From randomization through 168 hours
Hours Alive and Free of Invasive Ventilatory Support 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.
Time frame: From randomization through day 30
ICU-Free Days Alive 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.
Time frame: From randomization through day 30
Moderate or Severe Pain 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.
Time frame: At 1 month
Moderate or Severe Pain 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.
Time frame: At 6 months
Health-Related Quality of Life 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.
Time frame: At 6 months
Mobilization During ICU Care
Mobilization during ICU care categorized as ICU Mobility Scale greater than 1 versus 1 or lower.
Time frame: From randomization through 168 hours
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Oct 2023 (actual). Primary completion is estimated for May 2026, 31 months after the start.
Of 504 non-industry observational studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 31 months is above that.
Counting every sponsor, half of 519 studies reached it within 18 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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