Individualized Analgesia in the Intensive Care Unit With a New Pain Assessment Bundle and Protoco… (NCT07473115) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Individualized Analgesia in the Intensive Care Unit With a New Pain Assessment Bundle and Protocolized Analgesia Adjustments
Switzerland400 participantsStarted 2026-04-01
Plain-language summary
Both severe pain and opioid therapy are associated with negative effects. The experience of pain is common in the intensive care unit, but it is highly individual and difficult to assess, as patients are often unable to communicate. This especially applies to patients who are mechanically ventilated. Behavioral assessment tools can help to identify pain in this population, but do not register overdose of opioid therapy. The AlgiScan® delivers the Pupillary Pain Index (PPI), an objective assessment of nociception level, which has been shown to be useful in small studies with respect to reduction of opioid dose without leading to more pain.
New institutional protocols for the assessment of pain include the behavioral pain assessment tool Zurich Observational Pain Assessment (ZOPA) and the PPI. This project aims to evaluate the impact of the new institutional protocols on opioid administration and occurrence of pain compared to a historical cohort by analyzing routinely collected data during mechanical ventilation (Part A). In a second part (Part B), promising biomarkers for detection of pain, subjective ratings by nurses and physicians and an additional behavioral pain scale will be evaluated using an observational study design. After screening and enrolment (day 1/visit 1), characteristics of pain will be assessed on 4 occasions during 2 days (day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5). On visit 2 and 4, biomarkers (alpha-amylase, cortisol) will be sampled.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Part A
* Admission to the intensive care unit
* Adults (≥18 years) of all sex and gender
* Mechanical ventilation Part B
* Admission to the intensive care unit
* Adults (≥18 years) of all sex and gender
* mechanical ventilation
* Continuous opioid therapy
* Richmond Agitation Sedation Scale (RASS) ≤ -4
* Presumed duration of mechanical ventilation until the end of observations (until day 3)
* Established vascular access suitable for blood sampling independent of study inclusion (arterial line or central venous catheter)
Exclusion Criteria:
Part A
* None Part B
* Previous enrolment into the current investigation
* Tracheostomy
* Chronic opioid use
* Regional anaesthesia
* Implanted pacemaker device
* Allergy to silicone or ECG-electrodes
* Ophthalmologic disease (e.g. ocular trauma, glaucoma) or past eye surgery
* Fixed pupils
* Known or suspected neurologic disease (including hypoxic encephalopathy)
* Therapy with atropine or topical mydriatics in previous 24 hours or planned
* Therapy with systemic steroids in previous 24 hours or planned
* Therapy with neuromuscular blocking agents in previous 24 hours or planned
* Stomatitis
* Active oral or nasal bleeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oral morphine equivalent (OME) per day of mechanical ventilation.
Timeframe: Part A: during mechanical ventilation (up to 28 days)