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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723137
• Other study ID #: 10-3189
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: October 24, 2013
• Start date: May 2010
• Est. completion date: January 2013

Study information

• Verified date: October 2013
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3630
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Less than 18 years of age

• Decreased level of consciousness

• Inability to answer questions

• Prisoner

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No