Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales

NCT01723137 | Completed

• 1 other identifier: 10-3189
• Study Type: observational
• Target: 3,630
• Locations: 1 country
• Sites: 1

Brief Summary

Patient reported pain, stress, and anxiety measures have been found to be inter-related, but it is not known if they are all associated with receiving opiate medications. The objective of this study is to determine if patients' degree of reported pain, stress, or anxiety is associated with receiving opiate pain medications in the emergency department or at discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are eligible to participate in the study. Consenting patients complete Visual Analog Scales describing their perceived pain, stress, and anxiety from enrollment until discharge. Demographic data and administration of pain medication is also recorded. Visual Analog Scale scores among patients who received an opioid pain medicine in the emergency department and at discharge will be compared to those who did not.

Conditions

Acute Pain

Keywords

Pain; Pain measurement; Visual analog scale; Anxiety; Stress; Opioid; Emergency department; Demographics

Outcome Measures

Primary Outcomes (4)

• Change in Patient Described Stress

  Patients describe stress by completion of 100 mm Visual Analog Scale, bordered by the words "no stress" and "most stress possible".

  Immediately upon enrollment, every 30 minutes after until hospital discharge, and upon discharge, for up to 24 hours.

• Change in Patient described anxiety.

  Patients describe anxiety by completing 100mm Visual Analog Scale, bordered by the words "no anxiety" and "most anxiety possible".

  Immediately upon study enrollment, every 30 minutes post-enrollment, and upon hospital discharge, for up to 24 hours.

• Change in patient described satisfaction with ongoing treatment.

  Patients describe satisfaction with ongoing treatment by completion of 100mm Visual Analog Scale, bordered by the words "not satisfied at all" and "completely satisfied".

  Immeditately upon enrollment, every 30 minutes post-enrollment, and upon hospital discharge, up to 24 hours.

• Change in patient described pain.

  Patients describe pain by completing a 100mm Visual Analog Scale, bordered by the words "no pain" and "worst pain possible".

  Immediately upon enrollment, every 30 minutes post-enrollment, and upon discharge, for up to 24 hours.

Study Arms (1)

In pain

Patients who report pain greater than or equal to 3 out of 10 are eligible for this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency department at an urban county hospital.

You may qualify if:

• Reported pain greater than or equal to 3 out of 10

You may not qualify if:

• Less than 18 years of age
• Decreased level of consciousness
• Inability to answer questions
• Prisoner

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain; Anxiety Disorders; Emergencies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• James R Miner, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 7, 2012
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

US (1)