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Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04490369
Enrollment
175
Registered
2020-07-29
Start date
2020-12-07
Completion date
2021-04-30
Last updated
2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Comfort

Keywords

Procedural sedation, Cardiac Catheterization

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.

Interventions

None listed

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* English speaking * Coming to Duke University for Cardiac Catheterization

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026