- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01723137
Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales
October 24, 2013 updated by: Hennepin Healthcare Research Institute
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
3630
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients presenting to the emergency department at an urban county hospital.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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In pain
Patients who report pain greater than or equal to 3 out of 10 are eligible for this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Patient Described Stress
Time Frame: Immediately upon enrollment, every 30 minutes after until hospital discharge, and upon discharge, for up to 24 hours.
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Patients describe stress by completion of 100 mm Visual Analog Scale, bordered by the words "no stress" and "most stress possible".
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Immediately upon enrollment, every 30 minutes after until hospital discharge, and upon discharge, for up to 24 hours.
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Change in Patient described anxiety.
Time Frame: Immediately upon study enrollment, every 30 minutes post-enrollment, and upon hospital discharge, for up to 24 hours.
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Patients describe anxiety by completing 100mm Visual Analog Scale, bordered by the words "no anxiety" and "most anxiety possible".
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Immediately upon study enrollment, every 30 minutes post-enrollment, and upon hospital discharge, for up to 24 hours.
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Change in patient described satisfaction with ongoing treatment.
Time Frame: Immeditately upon enrollment, every 30 minutes post-enrollment, and upon hospital discharge, up to 24 hours.
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Patients describe satisfaction with ongoing treatment by completion of 100mm Visual Analog Scale, bordered by the words "not satisfied at all" and "completely satisfied".
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Immeditately upon enrollment, every 30 minutes post-enrollment, and upon hospital discharge, up to 24 hours.
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Change in patient described pain.
Time Frame: Immediately upon enrollment, every 30 minutes post-enrollment, and upon discharge, for up to 24 hours.
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Patients describe pain by completing a 100mm Visual Analog Scale, bordered by the words "no pain" and "worst pain possible".
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Immediately upon enrollment, every 30 minutes post-enrollment, and upon discharge, for up to 24 hours.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
October 31, 2012
First Submitted That Met QC Criteria
November 5, 2012
First Posted (Estimate)
November 7, 2012
Study Record Updates
Last Update Posted (Estimate)
October 25, 2013
Last Update Submitted That Met QC Criteria
October 24, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-3189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.