Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates

This study has been completed.

Sponsor:

Information provided by:

Children's Hospital of Philadelphia

ClinicalTrials.gov Identifier:

NCT00286143

First received: February 1, 2006

Last updated: September 14, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2006

Last Updated Date

September 14, 2009

Start Date ^ICMJE

February 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the difference in amount of Intravenous nalbuphine required after thoracotomy for lung resection in patients receiving epidural bupivacaine + fentanyl versus patients receiving epidural bupivacaine. [ Time Frame: First 48 hours post-operatively ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00286143 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

1. Determine in two treatment groups the difference in pain scores as measured by the CRIES pain scale ,the length of stay,the incidence of side effects (respiratory depression, bradypnea, bradycardia and urinary retention). [ Time Frame: 48 hours post-operatively ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates

Official Title ^ICMJE

Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome

Brief Summary

The study exams whether adding an opioid to the epidural infusion of a local anesthetic in neonates will significantly improve the quality of the postoperative analgesia.

Detailed Description

The purpose of this study is to evaluate the best pain medication to be infused in the epidural catheter. At CHOP, the medication infused in the epidural catheter following a chest operation in neonates is a local anesthetic (bupivacaine). However, even with this continuous infusion, neonates still require multiple doses of intravenous opioids (i.e. morphine) because of persistent or constant pain. The administration of intravenous opioids in neonates can have many side effects, such as respiratory depression (reduced breathing rate), sedation, urinary retention (inability to pass urine), itching, nausea and vomiting It has been well documented that by adding a small dose of any opioid to a local anesthetic given through an epidural catheter, the feeling of postoperative pain can be significantly improved in older children and in adults. It is not known whether the addition of an opioid to a local anesthetic is beneficial in neonates. In this study, we are comparing the standard local anesthetic (bupivacaine) with a combination of bupivacaine and a small dose of an opioid (fentanyl).

This is a randomized study and the type of medication given into the epidural catheter will be chosen on the day of the operation by a random drawing (like flipping a coin). Your child could receive one of the following:

bupivacaine 0.1%
bupivacaine 0.1% with fentanyl 2mcg/ml Neither you nor your doctors will know which arm of the study your child is in. In case of emergency, the pharmacy can tell your doctor what medication your child is receiving.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Congenital Cystic Adenomatoid Malformation

Intervention ^ICMJE

Drug: Fentanyl

Fentanyl is added to epidural Bupivacaine to be administered to neonates having thoracotomy for lung resections.

Other Name: Actiq®; Duragesic®; Fentora™; Ionsys™; Sublimaze®

Study Arm (s)

Active Comparator: A

Fentanyl added to Bupivacaine via epidural catheter.

Intervention: Drug: Fentanyl

Publications *

Ganesh A, Adzick NS, Foster T, Cucchiaro G. Efficacy of addition of fentanyl to epidural bupivacaine on postoperative analgesia after thoracotomy for lung resection in infants. Anesthesiology. 2008 Nov;109(5):890-4.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Infants 0-6 months of age who require a thoracotomy for lung resection.
Parents accept the placement of an epidural catheter.

Exclusion Criteria:

Premature infants
Patients allergic to fentanyl and/or bupivacaine.
Known medical contraindications. -

Gender

Both

Ages

up to 6 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00286143

Other Study ID Numbers ^ICMJE

2004-10-3988

Has Data Monitoring Committee

Responsible Party

Arjunan Ganesh, MBBS, Children's Anesthesiology Associates

Study Sponsor ^ICMJE

Children's Hospital of Philadelphia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Arjunan Ganesh, MD

Children's Hospital of Philadelphia

Information Provided By

Children's Hospital of Philadelphia

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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