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Review of Pain Management After Congenital Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01378663
First Posted: June 22, 2011
Last Update Posted: March 20, 2012
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 (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital
  Purpose
One of the main problems that faces children undergoing congenital cardiac surgery is posoperative pain management. PCAs (Patient Controlled Analgesia) and NCAs (Nurse Controlled Analgesia) are the main means of pain management here at NCH. In this study, the investigators will review the difference between different PCA and NCA modalities. Also, the investigators aim to find out if there are differences between age groups in terms of type of drug used, total drug used, side effects and length of use of the PCA or NCA.

Condition
Postoperative Pain Management

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Review of Pain Management After Congenital Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Aymen N Naguib, Nationwide Children's Hospital:

Enrollment: 92
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Post congenital cardiac surgery pain management
All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.

Detailed Description:

All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA will be included. Data will be collected from the pain team database and charts review. Data will include; patient's age, weight, sex, procedure, pain scores and sedation score during the times of PCA and NCA use, side effects (respiratory depression, nausea, vomitting, pruritus, itching and other).In addition we will record the total days of PCA and NCA use. We will also look at the incidence of changes done in the PCA/NCA and drug itself.

Identifying the ideal drug and dose based on the patient's age and procedure will allow us to take better care of our patients. Our patient population is peculiar in the fact that a big percentage of our patients are extubated in the Operating Room. For this reason, sedation and analgesia play an important role for our continued success in taking care of them.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.
Criteria

Inclusion Criteria:

  • All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.

Exclusion Criteria:

  • All patients that underwent congenital cardiac surgery from 2004 till 2010 and did not receive PCA or NCA for postoperative pain management.
  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): NCT01378663


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Aymen N Naguib, MD Nationwide Children's Hospital
  More Information

Publications:
Responsible Party: Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01378663     History of Changes
Other Study ID Numbers: IRB10-00058
First Submitted: June 21, 2011
First Posted: June 22, 2011
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by Aymen N Naguib, Nationwide Children's Hospital:
Congenital cardiac surgery
Postoperative pain management

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