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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01378663
Other study ID # IRB10-00058
Secondary ID
Status Completed
Phase N/A
First received June 21, 2011
Last updated March 19, 2012
Start date April 2010
Est. completion date December 2011

Study information

Verified date March 2012
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Howard RF, Lloyd-Thomas A, Thomas M, Williams DG, Saul R, Bruce E, Peters J. Nurse-controlled analgesia (NCA) following major surgery in 10,000 patients in a children's hospital. Paediatr Anaesth. 2010 Feb;20(2):126-34. doi: 10.1111/j.1460-9592.2009.03242.x. — View Citation

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