NCT01378663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

1.7 years

First QC Date

June 21, 2011

Last Update Submit

March 19, 2012

Conditions

Postoperative Pain Management

Keywords

Congenital cardiac surgeryPostoperative pain management

Study Arms (1)

Post congenital cardiac surgery pain management

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related 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.

    PMID: 20078810BACKGROUND

Study Officials

  • Aymen N Naguib, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pediatric Cardiothoracic Anesthesia

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 22, 2011

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(1)