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Quality of Postoperative Pain Management in Cardiac Surgical Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949429
First Posted: July 30, 2009
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  Purpose
The purpose of this study is to determine the incidence and risk factors of moderate to severe pain after cardiac surgery, and compare the preoperative pain expectation and postoperative pain experience in the same patient.

Condition
Postoperative Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Postoperative Pain Management in Cardiac Surgical Patients

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Number of the patients having pain score more than 4 out of 10 in 48 hour postoperatively [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • Risk factors of postoperative pain in cardiac surgical patients [ Time Frame: 48 hours ]
  • Patient's preoperative pain expectation and postoperative pain experience [ Time Frame: 72 hours ]

Enrollment: 300
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Objectives

  1. To study the incidence of moderate to severe pain in cardiac surgical patients 48 hour postoperatively.
  2. To study the risk factors of moderate to severe postoperative pain in cardiac surgical patients.
  3. To compare the preoperative pain expectation and postoperative pain experience in the same patient.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients scheduled for cardiac surgery in Siriraj Hospital
Criteria

Inclusion Criteria:

  • patients scheduled for cardiac surgery in Siriraj Hospital
  • age > 18

Exclusion Criteria:

  • unable to communicate with the patient
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949429


Locations
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Kasana Raksamani, MD Siriraj Hospital
  More Information

Responsible Party: Kasana Raksamani, Faculty of Medicine, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00949429     History of Changes
Other Study ID Numbers: Si306/2009
First Submitted: July 29, 2009
First Posted: July 30, 2009
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Mahidol University:
postoperative pain
cardiac surgery
risk factors

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms