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Quality of Postoperative Pain Management in Cardiac Surgical Patients

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00949429
First received: July 29, 2009
Last updated: July 21, 2011
Last verified: July 2011
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk factors of postoperative pain in cardiac surgical patients [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Patient's preoperative pain expectation and postoperative pain experience [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949429

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

No publications provided

Responsible Party: Kasana Raksamani, Faculty of Medicine, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00949429     History of Changes
Other Study ID Numbers: Si306/2009
Study First Received: July 29, 2009
Last Updated: July 21, 2011
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014