NCT07182851: PainICU

Prevalence of Pain in Mechanically Ventilated Patients in Intensive Care Units

Recruiting now Last updated 19 September 2025

What this trial tests

trial in Sedation and Analgesia in 370 participants. Currently enrolling.

Timeline

1 June 2025

Primary endpoint
20 December 2025

31 March 2026

Quick facts

Lead sponsor	Centro Universitário Augusto Motta
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	370
Start date	1 June 2025
Primary completion	20 December 2025
Estimated completion	31 March 2026
Sites	4 locations across Brazil

Conditions studied

• Sedation and Analgesia — all drugs for Sedation and Analgesia →
• Pain Intensity Assessment — all drugs for Pain Intensity Assessment →
• Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →

Sponsor

Centro Universitário Augusto Motta

Who can join

18 and older, any sex, with Sedation and Analgesia or Pain Intensity Assessment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Pain is a subjective symptom, a physiological response that is difficult to assess, which affects the body physically and/or emotionally. It is a common phenomenon among clinical and surgical patients in Intensive Care Units (ICU). And its effects are the combined results of physiological and behavioral aggressions caused by clinical conditions, immobility and the execution of common procedures in ICU's. The presence of pain appears to be independently associated with worse clinical outcomes, including higher infection rates, patient-ventilator asynchronies, delirium, prolonged mechanical ventilation (MV), length of hospital stay and higher healthcare costs. Objectives: To evaluate the prevalence of pain and its associated factors in mechanically ventilated surgical patients in ICU's. Methods: This is a cohort, prospective, multicenter study designed to estimate the prevalence of pain, its intensity, its associated factors, correlating them to outcomes such as patient-ventilator asynchrony rate, time to weaning, and 28-day mortality in mechanically ventilated patients. All research participants who meet the inclusion criteria and who are not using neuromuscular blockers, or have any other condition associated with altered pain perception, will be evaluated using the Behavioral Pain Scale (BPS) and the Critical Care Pain Observation Tool (CPOT) on the 2nd day of mechanical ventilation and on the first day of awakening, when the RASS scale is between 4 and -2. At the same time, data will be collected on the ongoing sedoanalegesia strategy, and the asynchrony index will be calculated \[(Nº of asynchronous ventilatory cycles/Nº of ventilatory cycles studied) \*100\]. The end point of the research will be 28 days, where the time until weaning, time until discharge or death will be established using the Kaplan-Meier estimators. Expected results: The prevalence of pain and its intensity is associated with the presence of patient-ventilator asynchronies and thus with harsh outcomes related to the length of stay in the ICU, time until weaning and thirty-day mortality in the ICU. It is estimated that there is agreement between the BPS and CPOT scales in mechanically ventilated patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.