Pain Management for Pectus Excavatum Repair

This study has been completed.

Study NCT00413582 Information provided by Children's Mercy Hospital Kansas City

First Received on December 18, 2006. Last Updated on December 12, 2011 History of Changes

Results First Received: December 12, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Postoperative Pain
Interventions:	Drug: Epidural Analgesia Drug: Patient-Controlled IV Analgesia

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from patients undergoing pectus excavatum repair.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients who consented were enrolled

Reporting Groups

	Description
Epidural Group	Epidural analgesia arm of study
PCA Group	IV narcotic analgesia arm of study

Participant Flow: Overall Study

[1]	all enrolled completed

Baseline Characteristics

Reporting Groups

	Description
Epidural Group	Epidural analgesia arm of study
PCA Group	IV narcotic analgesia arm of study

Baseline Measures

	Epidural Group	PCA Group	Total
Number of Participants [units: participants]	55	55	110
Age [units: participants]
<=18 years	49	53	102
Between 18 and 65 years	6	2	8
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	15.3 ± 2.84	13.55 ± 2.91	14.43 ± 2.99
Gender [units: participants]
Female	10	18	28
Male	45	37	82
Region of Enrollment [units: participants]
United States	55	55	110

Outcome Measures

1. Primary:

Length of Hospitalization [ Time Frame: 1 week ]

Show Outcome Measure 1

2. Secondary:

Time in the Operating Room [ Time Frame: 1 week ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
none

Results Point of Contact:

Name/Title: Shawn D. St. Peter, MD
Organization: Children's Mercy Hospital
phone: 816-983-6479
e-mail: sspeter@cmh.edu

No publications provided

Responsible Party:	Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00413582 History of Changes
Other Study ID Numbers:	06 08 128
Study First Received:	December 18, 2006
Results First Received:	December 12, 2011
Last Updated:	December 12, 2011
Health Authority:	United States: Institutional Review Board