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Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

Completed
Conditions
Patient Comfort
Registration Number
NCT04490369
Lead Sponsor
Duke University
Brief Summary

The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation.

Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
175
Inclusion Criteria
  • English speaking
  • Coming to Duke University for Cardiac Catheterization
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Exclusion Criteria
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total medication administration dosage as measured by the procedural databaseDuring procedure, up to 2.5 hours
Frequency of medication administration as measured by the procedural databaseDuring procedure, up to 2.5 hours
Secondary Outcome Measures
NameTimeMethod
Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)Within 2 hours of procedure
Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)During procedure, to 2.5 hours

Trial Locations

Locations (1)

Duke University

🇺🇸

Durham, North Carolina, United States

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