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OpenTrials
Completed

NCT Number: NCT04490369

Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking
  • Coming to Duke University for Cardiac Catheterization

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Total medication administration dosage as measured by the procedural database

    Time frame: During procedure, up to 2.5 hours

  2. Frequency of medication administration as measured by the procedural database

    Time frame: During procedure, up to 2.5 hours

Secondary outcomes

  1. Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)

    Time frame: Within 2 hours of procedure

  2. Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)

    Time frame: During procedure, to 2.5 hours

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2020
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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