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Pain Management for Pectus Excavatum Repair

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.
 
ClinicalTrials.gov Identifier: NCT00413582
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : January 16, 2012
Last Update Posted : January 16, 2012
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Postoperative Pain
Interventions Drug: Epidural Analgesia
Drug: Patient-Controlled IV Analgesia
Enrollment 110
Recruitment Details Patients were recruited from patients undergoing pectus excavatum repair.
Pre-assignment Details All patients who consented were enrolled
Arm/Group Title Epidural Group PCA Group
Hide Arm/Group Description Epidural analgesia arm of study IV narcotic analgesia arm of study
Period Title: Overall Study
Started 55 [1] 55 [1]
Completion of Study 55 [1] 55 [1]
Completed 55 [1] 55 [1]
Not Completed 0 0
[1]
all enrolled completed
Arm/Group Title Epidural Group PCA Group Total
Hide Arm/Group Description Epidural analgesia arm of study IV narcotic analgesia arm of study Total of all reporting groups
Overall Number of Baseline Participants 55 55 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
<=18 years
49
  89.1%
53
  96.4%
102
  92.7%
Between 18 and 65 years
6
  10.9%
2
   3.6%
8
   7.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 110 participants
15.3  (2.84) 13.55  (2.91) 14.43  (2.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Female
10
  18.2%
18
  32.7%
28
  25.5%
Male
45
  81.8%
37
  67.3%
82
  74.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 55 participants 110 participants
55 55 110
1.Primary Outcome
Title Length of Hospitalization
Hide Description [Not Specified]
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epidural Group PCA Group
Hide Arm/Group Description:
Epidural analgesia arm of study
IV narcotic analgesia arm of study
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: days
4.54  (1.01) 4.25  (1.00)
2.Secondary Outcome
Title Time in the Operating Room
Hide Description [Not Specified]
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epidural Group PCA Group
Hide Arm/Group Description:
Epidural analgesia arm of study
IV narcotic analgesia arm of study
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: hours
1.97  (.35) 1.58  (.33)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epidural Group PCA Group
Hide Arm/Group Description Epidural analgesia arm of study IV narcotic analgesia arm of study
All-Cause Mortality
Epidural Group PCA Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Epidural Group PCA Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epidural Group PCA Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shawn D. St. Peter, MD
Organization: Children's Mercy Hospital
Phone: 816-983-6479
EMail: sspeter@cmh.edu
Layout table for additonal information
Responsible Party: Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00413582    
Other Study ID Numbers: 06 08 128
First Submitted: December 18, 2006
First Posted: December 20, 2006
Results First Submitted: December 12, 2011
Results First Posted: January 16, 2012
Last Update Posted: January 16, 2012