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Review of Pain Management After Congenital Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01378663
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital

Study Description
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Brief Summary:
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 or disease
Postoperative Pain Management

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.

Study Design
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Study Type : Observational
Actual Enrollment : 92 participants
Time Perspective: Retrospective
Official Title: Review of Pain Management After Congenital Cardiac Surgery
Study Start Date : April 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Groups and Cohorts
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Group/Cohort
Post congenital cardiac surgery pain management
All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Aymen N Naguib, MD Nationwide Children's Hospital
More Information
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Publications:

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Responsible Party: Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01378663    
Other Study ID Numbers: IRB10-00058
First Posted: June 22, 2011    Key Record Dates
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:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations