Agitation | Stress Biomarkers Among Patients Undergoing Treatment for Excited Delirium and Severe Pain in the Emergency Department
Agitation research study
What is the primary objective of this study?
The purpose of this project is to determine the levels of stress biomarkers associated with severe pain, agitation from intoxication or psychosis, and excited delirium at various levels of the disease in order to compare them to pre-clinical models of law enforcement encounters. We hypothesize that the serum catecholamines and markers of metabolic acidosis will worsen with the duration and severity of agitation among agitated patients and will not worsen among patients with severe pain who are not agitated. Specific Aims - To assess the prevalence of patients undergoing treatment for agitation from any cause requiring restraint or sedation. - To assess the prevalence of excited delirium in the emergency department. - To determine the difference in serum total catecholamines, serum dopamine, serum epinephrine, serum norepinephrine, heart rate, systolic blood pressure, mean arterial pressure, mortality, and disposition among patients with agitation requiring restraint, including excited delirium and patients with severe pain from extremity fractures. - To describe changes in stress biomarkers among patients with changing levels of agitation as determined by the Altered Mental Status scale.
Who is eligible to participate?
Agitation Group Inclusion Criteria: - Patients with agitation as defined by an Altered Mental Status Score of >1, and who are in restraints or are given sedatives for treatment of agitation. Agitation Group Exclusion Criteria: - Less than 18 years of age - Suspected or confirmed pregnancy Pain Group Inclusion Criteria: - Patients with an extremity fracture who report their pain as severe. Pain Group Exclusion Criteria: - Less than 18 years of age - Suspected or confirmed pregnancy - Prisoner
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Agitation GroupPatients that are evaluated to have an altered mental status score greater than 1 will be enrolled in the Agitation Group.
Pain GroupPatients that report severe pain secondary to a long bone fracture or dislocation and report a visual analog scale pain score greater than 7 will be enrolled in the Pain Group.
Start Date: December 2012
Completed Date: December 2015
Primary Outcome: Change in Altered Mental Status Score
Secondary Outcome: Length of Hospital Stay
Study sponsors, principal investigator, and references
Principal Investigator: James R Miner, MD
Lead Sponsor: Minneapolis Medical Research Foundation
Collaborator: U.S. Department of Justice