Trial Outcomes & Findings for Pain Management for Pectus Excavatum Repair (NCT NCT00413582)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

1 week

Results posted on

2012-01-16

Participant Flow

Patients were recruited from patients undergoing pectus excavatum repair.

All patients who consented were enrolled

Participant milestones

Participant milestones
Measure	Epidural Group Epidural analgesia arm of study	PCA Group IV narcotic analgesia arm of study
Overall Study STARTED	55	55
Overall Study Completion of Study	55	55
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain Management for Pectus Excavatum Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epidural Group n=55 Participants Epidural analgesia arm of study	PCA Group n=55 Participants IV narcotic analgesia arm of study	Total n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	49 Participants n=99 Participants	53 Participants n=107 Participants	102 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants	2 Participants n=107 Participants	8 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age Continuous	15.3 years STANDARD_DEVIATION 2.84 • n=99 Participants	13.55 years STANDARD_DEVIATION 2.91 • n=107 Participants	14.43 years STANDARD_DEVIATION 2.99 • n=206 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	18 Participants n=107 Participants	28 Participants n=206 Participants
Sex: Female, Male Male	45 Participants n=99 Participants	37 Participants n=107 Participants	82 Participants n=206 Participants
Region of Enrollment United States	55 participants n=99 Participants	55 participants n=107 Participants	110 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 week

Outcome measures

Outcome measures
Measure	Epidural Group n=55 Participants Epidural analgesia arm of study	PCA Group n=55 Participants IV narcotic analgesia arm of study
Length of Hospitalization	4.54 days Standard Deviation 1.01	4.25 days Standard Deviation 1.00

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Outcome measures
Measure	Epidural Group n=55 Participants Epidural analgesia arm of study	PCA Group n=55 Participants IV narcotic analgesia arm of study
Time in the Operating Room	1.97 hours Standard Deviation .35	1.58 hours Standard Deviation .33

Adverse Events

Epidural Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PCA Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shawn D. St. Peter, MD

Children's Mercy Hospital

Phone: 816-983-6479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place