A Look Behind the PADIS Focused Update

The Society of Critical Care Medicine (SCCM) recently published “A Focused Update to the Clinical Practice Guidelines for the Prevention and Management of Pain, Anxiety, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption (PADIS) in Adult Patients in the ICU.”¹ The updated guideline expands on the 2018 guidelines,² by issuing five statements related to the management of anxiety (a new topic), agitation/sedation, delirium, immobility, and sleep disruption in adults in the intensive care unit (ICU).

Erika L. Setliff, DNP, RN, CCRN, ACNS-BC, FCCM, interviewed the methodology chair, Kimberley Lewis, MD, MSc, FRCPC. Dr. Lewis is an assistant professor in the Division of Critical Care at McMaster University in Hamilton, Ontario, Canada, an ICU physician, and was a lead author along with guideline panel co-chairs Michelle C. Balas, RN, PhD, CCRN, FAAN, FCCM, and J. Matthew Aldrich, MD, FCCM, and co-vice-chairs Joanna L. Stollings, PharmD, FCCM, and Molly McNett, RN, PhD, CNRN, FNCS, FAAN.
 

First, tell us a little bit about your experience leading this work.

It was exciting and enjoyable to collaborate with such a large group of diverse panelists from different parts of the world and varied occupations, all under the fantastic leadership of Drs. Aldrich, Balas, McNett, and Stollings. ICU liberation and sedation are subjects near and dear to my heart. I think they are integral to the compassionate care of every critically ill patient admitted to the ICU. It has been an honor to create this guideline to improve care not only for the patient right in front of me in my own institution, but also for patients worldwide.
 

What changes have you made in your own practice after being involved in this guideline update? 

I started using melatonin a lot more! This is something I have implemented in my daily practice as a critical care physician, along with increased attention to overall sleep quality. Even though many questions remain unanswered, a meta-analysis of 30 randomized controlled trials (RCTs) demonstrated that melatonin may improve delirium with very little risk compared with not using melatonin.

It was difficult to determine whether melatonin improves sleep quality in the ICU, largely because sleep and circadian rhythms are difficult (and expensive) to measure in clinical trials. So, although we still have questions about melatonin and its impact on sleep in this population, the guideline has led me to think about how I can improve patient sleep quality and quantity. For instance, if the patient is stable enough, I will be very cautious about the timing of vital sign checks and bloodwork, and try to order them outside of sleeping hours. 

Even feeding is something I try to give more attention to now. I work with my dietitian colleagues to schedule feeding during the day and not at night. All of these strategies allow the patient to have a window of uninterrupted time for sleep. I think our field of critical care could pay more attention to sleep in future research!

Overall, I am more cognizant about liberating patients from our ICU interventions and trying to make them feel normal, for example, removing Foley catheters and providing advanced diets as soon as possible. We want to remove the ICU from them as soon as it is safe to do so, which will likely reduce delirium. ICU care cannot be comfortable for the patient from anxiety, agitation, and pain perspectives. We should be liberating the patient from the ICU as soon as we can and always be asking ourselves, “What can we do to give them some normalcy during this chaotic experience?”
 

The recommendation for melatonin was new! It’s nice to see any focus on sleep, which is such a challenge in the ICU. You already spoke about incorporating this into your own practice. Were there any particular populations that seemed to derive the most benefit from melatonin?

Overall, melatonin was likely to be beneficial, with very little downside. Most trials in our meta-analyses enrolled patients who were admitted to general medical/surgical ICUs, while nine RCTs were conducted in neuro-ICUs, and five in cardiac ICUs. Subgroup analyses did not seem to show that any population benefited more than others.

There was a lot of heterogeneity in melatonin dosing, such as total amount, frequency, and timing of administration. The next RCT should be a head-to-head comparison of different doses and perhaps timing of melatonin, with outcomes examining sleep quality and quantity. 
 

Were you surprised by any findings in the updated literature?

What surprised me most was how the critical care community can rally to produce evidence for important topics! For instance, in 2018 there were three RCTs examining propofol versus dexmedetomidine compared to the 29 that we found for the 2025 PADIS update. Likewise, the 2018 PADIS guideline used three RCTs for melatonin versus no melatonin compared to the 30 RCTs that are now available! This really speaks to the power of the scientific community of critical care to identify new and emerging important topics and produce evidence to help us all!

However, other areas, such as benzodiazepine use to treat anxiety, are neglected research subjects, with very little direct evidence despite its ubiquitous use. Earlier PADIS iterations did not examine anxiety—likely a contributing factor to agitation that can be the result of delirium, pain, and thirst. We are poor at identifying anxiety, measuring it, and treating it. This could certainly be a large call to action for the critical care community.
 

I love the shift in nomenclature from “early” to “enhanced” mobilization. Can you expand a little on this change?

Every ICU has different patients, support staff, and resource availability. ICUs are not one-size-fits-all where you can universally apply a rule and expect all units to follow it. While some ICUs may be able to provide early mobilization, we recognize that others may not. But they can offer other forms of more aggressive physiotherapy, which we termed “enhanced mobilization.” This is reflected in the literature where we identified trials that were adding cycling and/or increasing the duration or frequency of mobilization, in addition to early or protocolized mobilization. 

Enhanced physiotherapy/rehabilitation just means additional exercise in any form compared to usual exercise. We found that enhanced mobilization compared to standard-of-care mobilization improves weakness, functional quality-of-life outcomes, and post-discharge measures.1 Also, more patients were able to go home if they received enhanced mobilization. This was exciting to see because it reflects some of the strongest data that we identified in the guideline.

We found that the enhanced mobilization groups did not experience significant adverse events such as inadvertent extubations or line removals. Hemodynamic stability was more or less maintained. We tried to pull the trials apart to determine whether any intervention was superior to others, but the interventions in the trials are so intertwined that subgroup analyses were difficult to conduct. Hence, our takeaway is that more is better for mobilization!
 

Given the lack of evidence on practices surrounding anxiety assessment and management in the ICU, what are your thoughts on where the research should focus to better answer these questions for future updates?

I suspect that physicians frequently administer benzodiazepines for anxiety, so it would be a reasonable topic to explore. An RCT exploring benzodiazepine versus nonpharmacologic interventions for anxiety would be a great starting point. Pragmatically, we all get anxious during normal daily life, and many of us have coping techniques that do not rely on medication. So perhaps there are better ways of helping patients through this very normal human emotion that would avoid a medication that can be sedating and induce delirium.

We also need validated anxiety detection and assessment tools for the ICU population. Faces anxiety scales have been validated in both intubated and nonintubated patients, but very few studies have been done in this area. 
 

Any closing thoughts from your experiences in leading this fantastic work? 

I want to acknowledge everyone who was involved in the guideline. It took hundreds of hours of work to do. Leadership was a pleasure to work with and learn from, and the panelists brought their enthusiasm and wealth of knowledge that made the guideline a fun project. The patient partners were involved from the first moment and gave their time to make sure that they were leaving their mark to improve patient experiences. SCCM staff always kept us on task and supported for meetings. Lastly, the systematic review and meta-analysis team was integral to the extraction of data in a timely manner. It really does take a village, and I am so fortunate to have been a part of it all.



References

1. Lewis K, Balas MC, Stollings JL, et al. A focused update to the clinical practice guideline for the prevention and management of pain, anxiety, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2025 Mar 1;53(3):e711-e727.
2. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873.