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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?

Agitation

Excited Delirium

Pain

Study Interventions

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.

Study Arms

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.

Study Status

Completed

Start Date: December 2012

Completed Date: December 2015

Phase:

Type: Observational

Design:

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

More information:https://clinicaltrials.gov/show/NCT01747824

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