Although potent sedative and opioid drugs are some of the most commonly used medications to manage pain, anxiety, and discomfort in critically ill patients, conducting clinical trials where sedative and opioid medications are outcome variables within a longitudinal research design can be a methodological challenge.
The purpose of this article is to provide in detail a conceptual discussion of the concept and analysis of sedative exposure: A novel research analysis method for aggregating sedative and opioid medication doses from disparate drug classes commonly administered to critically ill patients and used by our team in several clinical research studies.
Comparing the dose of each sedative and opioid administered to an individual patient (within a defined time interval) to all other patients in a research study receiving the same medications allows for ranking of dosages for each medication by quartiles. Rank values for all sedatives and opioids received can be summed to a single value resulting in a Sedation Intensity Score. In addition, a simple count of how many hours at least one dose of a sedative or opioid medication has been administered can determine sedation frequency.
This method can allow for comparison of sedative exposure with medications from disparate drug classes and for analysis of estimates of change in medication use over time.
This novel research analysis method can overcome the challenges and limitations of determining changes in sedative and opioid medication regimens in cohort and clinical trial study designs.
Mary Fran Tracy, PhD, RN, APRN, CNS, FAAN, is Associate Professor, University of Minnesota School of Nursing, and Nurse Scientist, University of Minnesota Medical Center, Minneapolis.
Linda Chlan, PhD, RN, ATSF, FAAN, is Associate Dean for Nursing Research and Professor of Nursing, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
Kay Savik, MS, is Senior Statistician, University of Minnesota School of Nursing, Minneapolis.
Debra J. Skaar, PharmD, FCCM, is Associate Professor of Experimental & Clinical Pharmacology, University of Minnesota College of Pharmacy, Minneapolis.
Craig Weinert, MD, MPH, is Professor of Medicine, Pulmonary, Allergy, Critical Care, and Sleep Medicine Division, University of Minnesota Medical School, Minneapolis.
Accepted for publication August 29, 2018.
Kay Savik is now retired.
The research method described in this article was developed from research projects supported by the Clinical and Translational Science Award (CTSA) program through the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS), Grant UL1TR002373, and the National Heart, Lung and Blood Institute, Grant R01 HL130881. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
The research analysis method described in this article was developed during several research grants, which were carried out following standards of ethical research conduct and with institutional review board approval. The data presented in this article are for illustrative purposes only and not actual data obtained from a research study.
The authors have no conflicts of interest to disclose.
Corresponding author: Mary Fran Tracy, PhD, RN, APRN, CNS, FAAN, University of Minnesota School of Nursing, 5-140 Weaver-Densford Hall, 308 Harvard St. SE, Minneapolis, MN 55455 (e-mail: email@example.com).